Actively Recruiting
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants
Led by Shenzhen Kexing Pharmaceutical Co., Ltd. · Updated on 2025-11-19
36
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who have signed informed consent and can comply with all study procedures
- Males and females aged 18 to 55 years inclusive
- Body weight at least 50 kg for males and 45 kg for females with BMI between 18.5 and 26 kg/m2 inclusive
- Overtly healthy as determined by medical evaluation including history, physical exam, vital signs, ECG, and lab tests
- Participants and their partners willing to use effective contraception from screening to 6 months after last dose
You will not qualify if you...
- History or evidence of significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases
- History or positive tests for HIV, syphilis, hepatitis B or C
- History of allergic or anaphylactic reactions to monoclonal antibodies
- History of recurrent or active infections
- Recent or active suicidal ideation or other conditions increasing study risk
- Smoking more than five cigarettes daily or habitual nicotine use
- Use of drugs, dietary or herbal supplements within 7 days before dosing
- Exposure to live vaccines within 28 days before screening
- Previous investigational drug use within defined recent periods
- History of drug abuse within 5 years or positive drug test at screening
- Elevated blood pressure or ECG abnormalities affecting safety
- Abnormal liver function tests or history of alcohol/drug abuse within 3 months
- Recent blood donation within 60 days
- Skin issues at injection site
- History of vasovagal syncope or needle phobia
- Plans to donate sperm or oocytes within 6 months after dosing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
K
Kangsheng Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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