Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-05-01
44
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult male or female participants aged 18 to 45 years inclusive at the time of informed consent
- Male body weight of at least 50 kg and female body weight of at least 45 kg at screening
- Body mass index between 18 and 28 kg/m² inclusive
- Good general health based on medical history, exams, vital signs, ECG, lab tests, and imaging
- Participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after last dose
- No plans for conception, sperm or egg donation, or egg cryopreservation from consent until 6 months after last dose
- Female participants must have had no unprotected sexual intercourse within 14 days prior to first dose
- Ability and willingness to understand and comply with study requirements and complete follow-up visits
You will not qualify if you...
- History of hypersensitivity to GenSci161, any excipients, similar compounds, or allergic diseases
- Severe trauma or major surgery within 12 months prior to screening or planned surgery during trial
- Active significant systemic or local infection from 4 weeks prior to screening until randomization
- Intolerance to abdominal subcutaneous injection or skin issues at injection site interfering with assessment
- Clinically significant, poorly controlled chronic disease or organ dysfunction affecting study conduct
- Positive screening for hepatitis C, HIV, syphilis, or hepatitis B infection
- Use of live or live-attenuated vaccine within 12 weeks prior to screening or planned during trial (except inactivated flu vaccine)
- Any condition judged by investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
S
ShuQin Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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