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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants

NCTNCT03859323 (opens ClinicalTrials.gov in a new tab)Other idSHP681-101
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 1
Enrollment
104 participants (actual)
Sponsor
Shire · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
26 Mar 2019
Primary completion
6 Jan 2020
Completion
6 Jan 2020
First posted
1 Mar 2019
Last update posted
25 Feb 2021
Conditions
Healthy Volunteers

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 1

    A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants

    NCT03859323

    26 Mar 2019 to 6 Jan 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to assess the safety and tolerability of single and multiple ascending subcutaneous (SC) doses of SHP681 in healthy adult participants.

Interventions

  • SHP681Drug
  • PlaceboOther

Arms12

  • Experimental

    Single Ascending Dose (SAD): 0.2 mg/kg

    Participants will receive single subcutaneous (SC) injection of 0.2 mg/kg SHP681 in the abdomen.

  • Experimental

    Single Ascending Dose (SAD): 0.5 mg/kg

    Participants will receive single SC injection of 0.5 mg/kg SHP681 in the abdomen.

  • Experimental

    Single Ascending Dose (SAD): 1 mg/kg

    Participants will receive single SC injection of 1 mg/kg SHP681 in the abdomen.

  • Experimental

    Single Ascending Dose (SAD): 2 mg/kg

    Participants will receive single SC injection of 2 mg/kg SHP681 in the abdomen.

  • Experimental

    Single Ascending Dose (SAD): 4 mg/kg

    Participants will receive single SC injection of 4 mg/kg SHP681 in the abdomen.

  • Placebo comparator

    Single Ascending Dose (SAD): Placebo

    Participants will receive single SC injection of placebo matched to SHP681 in the abdomen.

  • Experimental

    Multiple Ascending Dose (MAD): 0.2 mg/kg

    Participants will receive SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen.

  • Experimental

    Multiple Ascending Dose (MAD): 0.5 mg/kg

    Participants will receive SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen.

  • Experimental

    Multiple Ascending Dose (MAD): 1 mg/kg

    Participants will receive SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen.

  • Experimental

    Multiple Ascending Dose (MAD): 2 mg/kg

    Participants will receive SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen.

  • Experimental

    Multiple Ascending Dose (MAD): 4 mg/kg

    Participants will receive SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen.

  • Placebo comparator

    Multiple Ascending Dose (MAD): Placebo

    Participants will receive SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD)

    Time frame · From start of study drug administration up to follow-up (Day 29 for SAD)

    Registry description

    Adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD)

    Time frame · From start of study drug administration up to follow-up (Day 57 for MAD)

    Registry description

    AE was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.

  3. Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Single Ascending Dose (SAD) at Day 29

    Time frame · Day 29

    Registry description

    Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in SAD at Day 29 were reported.

  4. Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 36

    Time frame · Day 36

    Registry description

    Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 36 were reported.

  5. Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 57

    Time frame · Day 57

    Registry description

    Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 57 were reported.

Secondary outcomes(20)

  1. Maximum Observed Plasma Concentration (Cmax) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    Cmax of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  2. Time of the Last Measurable Concentration (Tlast) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    tlast of SHP681 during SAD was reported.

  3. Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    tmax of SHP681 during SAD was reported.

  4. Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    AUC0-last of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  5. Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    AUC0-inf of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  6. Terminal Half-life (t1/2) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    t1/2 of SHP681 during SAD was reported.

  7. Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24 hours post-dose

    Registry description

    Cavg,0-24 of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  8. First Order Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    Lambda z of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  9. Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUC0-inf (CL/F) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    CL/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  10. Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 During Single Ascending Dose (SAD)

    Time frame · Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

    Registry description

    Vz/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  11. Average Concentration From Time Zero to 24 Hours Post First Dose (Cavg,0-24) of SHP681 Post First Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24 hours post-dose on Day 1

    Registry description

    Cavg,0-24 of SHP681 post first dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  12. Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD)

    Time frame · Pre-dose on Days 8, 15, 22 and 29

    Registry description

    Ctrough of SHP681 for the First 5 cohorts and immediately before 2nd and 3rd dose of the 6th MAD cohort during MAD was reported.

  13. Maximum Concentration During the Dosing Interval Occurring at Tmax (Cmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    Cmax of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  14. Time of the Last Measurable Concentration (Tlast) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    Tlast of SHP681 post fifth dose during MAD was reported.

  15. Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    tmax of SHP681 post fifth dose during MAD was reported.

  16. Area Under the Curve for the Defined Interval Between Doses (Only Calculated if Interpretable) (AUC0-tau) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    AUC0-tau of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  17. Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    AUC0-last of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  18. Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    AUC0-inf of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  19. Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    Cavg,0-24 of SHP681 during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

  20. Terminal Half-life (t1/2) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)

    Time frame · 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29

    Registry description

    t1/2 of SHP681 post fifth dose during MAD was reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From start of study drug administration up to follow-up (Day 29 for SAD)

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD)

GroupValue (Participants)
Part 1: Single Ascending Dose (SAD): Placebo3
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg3
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg2
Part 1: Single Ascending Dose (SAD): 1 mg/kg4
Part 1: Single Ascending Dose (SAD): 2 mg/kg3
Part 1: Single Ascending Dose (SAD): 4 mg/kg2
Primary outcomeCount of participants· From start of study drug administration up to follow-up (Day 57 for MAD)

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD)

GroupValue (Participants)
Part 2: Multiple Ascending Dose (MAD): Placebo9
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg8
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg3
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg6
Part 2: Multiple Ascending Dose (MAD): 2 mg/kg5
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg9
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)8
Primary outcomeCount of participants· Day 29

Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Single Ascending Dose (SAD) at Day 29

GroupValue (Participants)
Part 1: Single Ascending Dose (SAD): Placebo0
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg0
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg0
Part 1: Single Ascending Dose (SAD): 1 mg/kg0
Part 1: Single Ascending Dose (SAD): 2 mg/kg0
Part 1: Single Ascending Dose (SAD): 4 mg/kg0
Primary outcomeCount of participants· Day 36

Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 36

GroupValue (Participants)
Part 2: Multiple Ascending Dose (MAD): Placebo0
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg0
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg1
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg2
Part 2: Multiple Ascending Dose (MAD): 2 mg/kg0
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg0
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)0
Primary outcomeCount of participants· Day 57

Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 57

GroupValue (Participants)
Part 2: Multiple Ascending Dose (MAD): Placebo0
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg0
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg1
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg1
Part 2: Multiple Ascending Dose (MAD): 2 mg/kg1
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg1
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)0
Secondary and other outcome results(3)
Secondary outcomeGeometric mean· Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Maximum Observed Plasma Concentration (Cmax) of SHP681 During Single Ascending Dose (SAD)

GroupValue (Micrograms per milliliter (mcg/mL))Spread
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg0.839973.2
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg1.51527.7
Part 1: Single Ascending Dose (SAD): 1 mg/kg4.20026.8
Part 1: Single Ascending Dose (SAD): 2 mg/kg8.64728.4
Part 1: Single Ascending Dose (SAD): 4 mg/kg18.3925.2
Secondary outcomeMedian· Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Time of the Last Measurable Concentration (Tlast) of SHP681 During Single Ascending Dose (SAD)

GroupValue (Hour)
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg335.0
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg504.0
Part 1: Single Ascending Dose (SAD): 1 mg/kg673.0
Part 1: Single Ascending Dose (SAD): 2 mg/kg672.0
Part 1: Single Ascending Dose (SAD): 4 mg/kg672.0
Secondary outcomeMedian· Pre-dose, 3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose

Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 During Single Ascending Dose (SAD)

GroupValue (Hour)
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg24.00
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg72.00
Part 1: Single Ascending Dose (SAD): 1 mg/kg48.00
Part 1: Single Ascending Dose (SAD): 2 mg/kg72.00
Part 1: Single Ascending Dose (SAD): 4 mg/kg72.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part 1: Single Ascending Dose (SAD): PlaceboParticipants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.0 / 50 / 53 / 5
Part 1: Single Ascending Dose (SAD): 0.2 mg/kgParticipants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.0 / 50 / 53 / 5
Part 1: Single Ascending Dose (SAD): 0.5 mg/kgParticipants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.0 / 50 / 52 / 5
Part 1: Single Ascending Dose (SAD): 1 mg/kgParticipants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.0 / 50 / 54 / 5
Part 1: Single Ascending Dose (SAD): 2 mg/kgParticipants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.0 / 50 / 53 / 5
Part 1: Single Ascending Dose (SAD): 4 mg/kgParticipants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.0 / 50 / 52 / 5
Part 2: Multiple Ascending Dose (MAD): PlaceboParticipants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.0 / 120 / 129 / 12
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kgParticipants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.0 / 100 / 108 / 10
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kgParticipants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.0 / 100 / 103 / 10
Part 2: Multiple Ascending Dose (MAD): 1 mg/kgParticipants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.0 / 100 / 106 / 10
Part 2: Multiple Ascending Dose (MAD): 2 mg/kgParticipants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.0 / 101 / 105 / 10
Part 2: Multiple Ascending Dose (MAD): 4 mg/kgParticipants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.0 / 120 / 129 / 12
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.0 / 100 / 108 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ability to voluntarily provide written, signed, and dated informed consent to participate in the study. * An understanding, ability, and willingness to fully comply with study procedures and restrictions. * Age 18-50 inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit. * Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. * Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease or condition based on a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, and urinalysis. * Body mass index between 18.0 kilograms per square meter (kg/m\^2) and 30.0 kg/m\^2 inclusive with a body weight 50-100 kg (110-220 pounds \[lbs\]). This inclusion criterion will only be assessed at the first screening visit. Exclusion Criteria: * History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments. * Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. * Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients. * Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product. * Known history of alcohol or other substance abuse within the last year. * Donation of blood or blood products (example \[eg\], plasma or platelets) within 60 days prior to receiving the first dose of investigational product. * Within 30 days prior to the first dose of investigational product: 1. Have used an investigational product (if elimination half-life is less than (\<) 6 days, otherwise 5 half-lives). 2. Have been enrolled in a clinical study. 3. Have had any substantial changes in eating habits, as assessed by the investigator. * Use of dipeptidyl peptidase (DPP)-4 inhibitors within 30 days or 5 half-lives, whichever is greater, prior to administration of the investigational product. * Confirmed systolic blood pressure greater than (\>) 139 millimeters of mercury (mmHg) or \<89mmHg, and diastolic blood pressure \> 89mmHg or \<49 mmHg. * Twelve-lead ECG demonstrating corrected QT interval by Fredericia (QTcF) \>450 millisecond (msec) at screening. If QTcF exceeds 450 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF values should be used to determine the participant's eligibility. * Positive screen for alcohol or illicit drugs at screening or Day -1. * Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. (1 alcohol unit equal to \[=\] 1 beer or 1 wine (5 ounce \[oz\] per 150 milliliter \[mL\]) or 1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol). * Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen. * Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product. * Routine consumption of more than 2 units of caffeine per day or participants who experience headaches associated with caffeine withdrawal. (1 caffeine unit is contained in the following items: one 6 oz (180 mL) cup of coffee, two 12 oz (360 mL) cans of cola, one 12 oz cup of tea, three 1 oz (85 g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine). * Prior screen failure (unless Sponsor approval is given), randomization, participation, or enrollment in this study or prior exposure to any GLP-2 analogs. * Unresected gastrointestinal (GI) polyp, known polyposis condition, or premalignant changes in the GI tract. * Any history of malignancy in the GI tract or treatment for any other malignancy in the previous 5 years. * Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of hormonal replacement therapy or hormonal contraceptives and occasional use of ibuprofen or acetaminophen and pre-approved medication for sedation or other medications required during or after the endoscopy). Current use is defined as use within 14 days of the first dose of investigational product. * Findings of subclinical hepatobiliary disease, such as gallstones, on abdominal ultrasound at screening as determined by the Investigator in consultation with the Medical Monitor.

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