At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 68 enrolled
Drug / intervention
14028 injection +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ，Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study
In Brief
A Phase 1 clinical trial evaluating 14028 injection and dulaglutide injection for Type 2 Diabetes. Completed, enrolled 68 participants across 1 site.
Detailed Summary
To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartMay 2022
Primary CompletionJul 2022
Study CompletionJul 2022
First PostedJul 2022
TodayJul 2026
First PostedJul 14, 2022
Enrollment StartMay 31, 2022
Primary CompletionJul 2, 2022
Study CompletionJul 8, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.0 years ago
Interventions
14028 injectionbiological
14028 injection, single dose, s.c. injection
dulaglutide injectionbiological
dulaglutide injection(TRULICITY®), single dose, s.c. injection