Actively Recruiting
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-03-25
48
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
CONDITIONS
Official Title
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 45 years at the time of signing informed consent
- Male body weight at least 50 kg or female body weight at least 45 kg
- Body mass index (BMI) between 18 and 28 kg/m2 at screening
- Males of reproductive age and females of childbearing potential agree to use highly effective contraception from screening to study end
- Females of childbearing potential must have a negative pregnancy test at screening and not be breastfeeding
- Able to understand trial procedures, voluntarily participate, sign informed consent, and complete the study
You will not qualify if you...
- Known allergy or serious hypersensitivity to GenSci136 or its components
- Presence of tattoo, sunburn, scar, or other factors interfering with injection site assessment
- History or presence of significant metabolic, skin, liver, kidney, blood, heart, gastrointestinal, neurological, respiratory, or other major disease affecting study evaluation
- Major surgery within 3 months before screening or planned elective surgery during the study
- History of surgery affecting drug absorption, distribution, metabolism, or excretion
- Positive alcohol breath test or drug abuse within specified time frames
- Use of soft drugs within 3 months or hard drugs within 1 year prior to screening
- Positive drug screening for specified substances
- Judged ineligible by investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
J
Jingsi Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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