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Trial · Interventional

CompletedPhase 1Registry data

A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants

NCTNCT05096598 (opens ClinicalTrials.gov in a new tab)Other idZP8396-21037Other id2021-001712-28Other idU1111-1267-1489
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Overview

Status
Completed
Phase
Phase 1
Enrollment
64 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Germany

Start
19 Oct 2021
Primary completion
12 Jan 2023
Completion
12 Jan 2023
First posted
27 Oct 2021
Last update posted
17 Jan 2023
Conditions
Overweight · Healthy Volunteers

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 1

    A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants

    NCT05096598

    19 Oct 2021 to 12 Jan 2023

Registry summary

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

The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics). Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.). Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.

Interventions

  • ZP8396Drug
  • Placebo (ZP8396)Drug

Arms2

  • Experimental

    ZP8396

    Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment.

  • Placebo comparator

    Placebo (ZP8396)

    In each of the 10 single dose cohorts, 2 subjects will receive placebo.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame · From dosing (Day 1) to end of trial (Day 50)

Secondary outcomes(20)

  1. Pharmacokinetics (PK) of ZP8396 (AUCτ)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Area under the plasma concentration-time curve over a dosing interval

  2. Pharmacokinetics (PK) of ZP8396 (AUCinf)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Area under the plasma concentration-time curve from time zero to infinity

  3. Pharmacokinetics (PK) of ZP8396 (AUClast)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration

  4. Pharmacokinetics (PK) of ZP8396 (Cmax)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Maximum (peak) plasma drug concentration

  5. Pharmacokinetics (PK) of ZP8396 (tmax)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Time to reach maximum (peak) plasma concentration

  6. Pharmacokinetics (PK) of ZP8396 (λz)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Elimination rate constant

  7. Pharmacokinetics (PK) of ZP8396 (t½)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Elimination half-life

  8. Pharmacokinetics (PK) of ZP8396 (Vz/f)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Apparent volume of distribution during terminal phase

  9. Pharmacokinetics (PK) of ZP8396 (Vz)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Volume of distribution during the terminal phase (i.v. only)

  10. Pharmacokinetics (PK) of ZP8396 (CL/f)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Apparent total clearance of the drug from plasma

  11. Pharmacokinetics (PK) of ZP8396 (CL)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Total body clearance of the drug (i.v. only)

  12. Pharmacokinetics (PK) of ZP8396 (MRT)

    Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

    Registry description

    Mean residence time

  13. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  14. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  15. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  16. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  17. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  18. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  19. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Area under the Plasma Glucose (PG) concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  20. Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)

    Time frame · 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

    Registry description

    Area under the Plasma Glucose (PG) concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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
Male
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy male subject * Body Mass Index (BMI) between 21.0 and 29.9 kg/m\^2, both inclusive * Body weight of at least 70.0 kg * Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent * Further inclusion criteria apply Exclusion Criteria: * History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke * Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg * Symptoms of arterial hypotension * Further exclusion criteria apply

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