Actively Recruiting
A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci136 for Injection in Healthy Adult Participants in China
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-03-25
48
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GenSci136 in healthy adult volunteers. This randomized, double-blind, placebo-controlled Phase 1 trial aims to study a single subcutaneous injection of GenSci136. The study focuses on how the drug behaves in the body and its effects, while monitoring for any adverse reactions over time. Participants will receive single ascending doses of GenSci136 or a placebo administered under the skin. The study is designed with dose escalation to evaluate different amounts of the drug. Both the experimental drug and placebo are given through subcutaneous injections in a controlled setting. During the study, participants will be closely observed from Day 1 through Day 113. Researchers will monitor for treatment-emergent adverse events and serious adverse events to assess safety. Blood samples will be collected to measure drug concentration, its maximum level, time to reach maximum level, elimination half-life, and other pharmacokinetic parameters. In addition, changes in specific biomarkers related to immune response will be measured. The trial involves regular visits and assessments over approximately 16 weeks to ensure thorough monitoring and data collection.
CONDITIONS
Brief 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; BMI between 18 and 28 kg/m2 at screening.
- Males of reproductive age and females of childbearing potential must agree to use highly effective contraception during the study and not plan conception or donation; females must have a negative pregnancy test and not be breastfeeding.
- Able to understand trial procedures, voluntarily participate, sign informed consent, follow trial requirements, and complete the study.
You will not qualify if you...
- Known allergy or serious hypersensitivity to GenSci136 or its ingredients, or history of serious allergic reactions to drugs, compounds, food, or other substances.
- Presence of tattoo, sunburn, scar, or other factors interfering with injection site assessment.
- History or presence of significant metabolic, skin, liver, kidney, blood, heart, digestive, neurological, respiratory, or other major diseases that could affect study evaluation.
- Major surgery within 3 months before screening, planned elective surgery during the study, or past surgery affecting drug absorption or metabolism.
- Positive alcohol breath test, recent drug abuse or use of drugs such as marijuana within 3 months, or harder drugs within 1 year before screening, or positive drug screening.
- Judged ineligible by the investigator for other reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 113 days
Participants receive a single subcutaneous injection of either GenSci136 or placebo to evaluate safety and pharmacokinetics.
Multiple visits for safety and pharmacokinetic assessments from Day 1 to Day 113
Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
J
Jingsi Li
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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