Trials / Recruiting
RecruitingNCT07237464
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd. · Network
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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 at a ratio of 3:1, with 3 participants receiving GB18 and 1 participant receiving placebo in Cohort A1, and 6 participants receiving GB18 and 2 participants receiving placebo in the remaining cohorts (A2-A5). Healthy participants will be screened within 28 days prior to dosing. Participants will be admitted to the Clinical Research Unit (CRU) on Day -1 and receive a single subcutaneous dose of GB18 or placebo on Day 1 at the abdomen. Participants will receive safety assessments on Day 8 and can be discharged with the permission of the investigator. Safety assessments and PK/PD/immunogenicity sampling will be carried out at scheduled timepoints. The participants will return to the CRU on Day 10, 15, 29, 50, 71, 92, 106 and 127 for blood sampling, safety, and other assessments such as vital signs, ECG, and laboratory test etc. 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. The Safety Review Committee (SRC) will assess the safety data, PK data and available PD data at least up to Day 15 (Cohort A1-2)/29 (Cohort A3-5) after the dose administration of each cohort, and a decision of whether to escalate to the next higher dose level or adjust the dose or discontinue dosing will be made by the SRC. For the safety of participants, 2 sentinel participants will be randomly dosed (GB18: placebo=1:1) at least 24 hours before the remaining participants in the cohort receive dosing, except for Cohort A1. Once safety is confirmed, the remaining participants will be dosed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | Placebo | Placebo will be administered to participants at doses matching GB18. |
Timeline
- Start date
- 2025-10-28
- Primary completion
- 2026-01-20
- Completion
- 2026-04-20
- First posted
- 2025-11-19
- Last updated
- 2025-11-19
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07237464. Inclusion in this directory is not an endorsement.