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To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants
Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.
Summary
This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18. A total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo. The arms of this study include: To evaluate the safety and tolerability of GB18 following a single subcutaneous (SC) administered dose in healthy adult participants. To characterize the serum pharmacokinetics (PK) of GB18 following a single SC administered dose in healthy adult participants. To characterize the pharmacodynamics (PD) of a single SC administration of GB18 on circulating GDF15 concentrations in healthy adult participants. To evaluate the immunogenicity profile of GB18 in healthy adult participants. To evaluate the effect of GB18 on body weight in healthy adult participants. To preliminary evaluation of the relationship between GB18 serum concentration and QTc interval after a single SC administration in healthy adult participants.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Following Single Subcutaneous Injection in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-10-28
Completion Date
2026-04-20
Last Updated
2025-11-19
Healthy Volunteers
Yes
Interventions
GB18 injection
GB18 will be administered to participants at a starting dose of 50 mg and increasing to 100, 200, 400 and 600 mg in sequential dosing cohorts.
Placebo
Placebo will be administered to participants at doses matching GB18.
Locations (1)
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China