NCT05459285

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	14028 injection	14028 injection, single dose, s.c. injection
BIOLOGICAL	dulaglutide injection	dulaglutide injection(TRULICITY®), single dose, s.c. injection

Timeline

• Start date: 2022-05-31
• Primary completion: 2022-07-02
• Completion: 2022-07-08
• First posted: 2022-07-14
• Last updated: 2022-08-25

Locations

1 site across 1 country: China