A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity®) in healthy Chinese subjects.

Gao X, Di Y, Lv Y, Luan Y, Xiong Y, Xu Y, Li Y, Guo L, Li X, Deng L, Zhuang Y, Hou J

Clinical and translational science1 Apr 2024Cited by 2 (Europe PMC)

PMID38651744PMCIDPMC11036873DOI10.1111/cts.13775PepBankPUB-38651744

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialPharmacokinetics
In healthy Chinese men, dulaglutide and HEC14028 met pharmacokinetic equivalence criteria for maximum plasma concentration.
In plain wordsIn healthy Chinese men, dulaglutide and HEC14028 met equivalence criteria for peak blood concentration.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeMaximum plasma concentration equivalence
Study
n = 68
Comparator
HEC14028
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Measurements
Cmax geometric mean ratio 90% CI
102.9 to 122%
HEC14028 and dulaglutide, single 0.75 mg dose
Source sentences
Summary
The study results showed that HEC14028 and dulaglutide were pharmacokinetically equivalent: 90% confidence interval (CI) of C_max and AUC_0-∞ geometric mean ratios were 102.9%-122.0% and 97.1%-116.9%, respectively, which were both within the range of 80.00%-125.00%.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174401
02HumanRandomized controlled trialPharmacokinetics
In healthy Chinese men, dulaglutide and HEC14028 met pharmacokinetic equivalence criteria for total exposure.
In plain wordsIn healthy Chinese men, dulaglutide and HEC14028 met equivalence criteria for total drug exposure.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeAUC equivalence
Study
n = 68
Comparator
HEC14028
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Measurements
AUC0-inf geometric mean ratio 90% CI
97.1 to 116.9%
HEC14028 and dulaglutide, single 0.75 mg dose
Source sentences
Summary
The study results showed that HEC14028 and dulaglutide were pharmacokinetically equivalent: 90% confidence interval (CI) of C_max and AUC_0-∞ geometric mean ratios were 102.9%-122.0% and 97.1%-116.9%, respectively, which were both within the range of 80.00%-125.00%.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174402
03HumanRandomized controlled trialSafety outcome
In healthy Chinese men receiving dulaglutide or HEC14028, no grade 3 or higher treatment-emergent adverse events occurred.
In plain wordsIn healthy Chinese men, neither dulaglutide nor HEC14028 had grade 3 or higher treatment-emergent adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedGrade 3 or higher adverse events
Study
n = 68
Comparator
HEC14028
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Source sentences
Summary
No grade 3 or above treatment emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to withdrawal from the trial, or TEAEs leading to death were reported in this study.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174403
04HumanRandomized controlled trialSafety outcome
In healthy Chinese men, no serious adverse events occurred with dulaglutide or HEC14028.
In plain wordsIn healthy Chinese men, neither dulaglutide nor HEC14028 had serious adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedSerious adverse events
Study
n = 68
Comparator
HEC14028
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Source sentences
Summary
No grade 3 or above treatment emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to withdrawal from the trial, or TEAEs leading to death were reported in this study.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174404
05HumanRandomized controlled trialSafety outcome
In healthy Chinese men, no treatment-emergent adverse events led to withdrawal with dulaglutide or HEC14028.
In plain wordsIn healthy Chinese men, no treatment-emergent adverse events caused trial withdrawal with dulaglutide or HEC14028.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedAdverse events leading to withdrawal
Study
n = 68
Comparator
HEC14028
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Source sentences
Summary
No grade 3 or above treatment emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to withdrawal from the trial, or TEAEs leading to death were reported in this study.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174405
06HumanRandomized controlled trialSafety outcome
In healthy Chinese men, no treatment-emergent adverse events led to death with dulaglutide or HEC14028.
In plain wordsIn healthy Chinese men, no treatment-emergent adverse events caused death with dulaglutide or HEC14028.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedAdverse events leading to death
Study
n = 68
Comparator
HEC14028
Outcome group
Mortality · Whole body
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Source sentences
Summary
No grade 3 or above treatment emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to withdrawal from the trial, or TEAEs leading to death were reported in this study.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174406
07HumanRandomized controlled trialSafety outcome
In healthy Chinese men, dulaglutide and HEC14028 had similar safety profiles.
In plain wordsIn healthy Chinese men, dulaglutide and HEC14028 had similar safety profiles.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeOverall safety profile
Study
n = 68
Comparator
HEC14028
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Source sentences
Summary
Both HEC14028 and dulaglutide showed good and similar safety profiles, and no incremental immunogenicity was observed in subjects receiving HEC14028 and dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174407
08HumanRandomized controlled trialSafety outcome
In healthy Chinese men, no incremental immunogenicity was observed with dulaglutide and HEC14028.
In plain wordsIn healthy Chinese men, dulaglutide and HEC14028 showed no increase in immunogenicity.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeImmunogenicity
Study
n = 68
Comparator
HEC14028
Outcome group
Immune response · Immune and inflammation
Studied dose
0.75 mg single dose · abdominal subcutaneousAs given in this study (human).
Source sentences
Summary
Both HEC14028 and dulaglutide showed good and similar safety profiles, and no incremental immunogenicity was observed in subjects receiving HEC14028 and dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period.
Summary · context
A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose).
Report a problemFND-3865174408

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT05459285

A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Sunshine Lake Pharma Co., Ltd.n = 6831 May 2022 to 8 Jul 2022

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 25 Aug 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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