Subcutaneous GenSci136 given to healthy adults to check safety and body behavior

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.

This trial tests whether a single or repeated subcutaneous dose of GenSci136 is safe and how it behaves in the body of healthy adults aged 18–45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07366866 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial enrolling healthy adult volunteers to receive subcutaneous GenSci136 or placebo. The trial focuses on safety and tolerability alongside pharmacokinetic (PK) and pharmacodynamic (PD) measurements. Participants will be monitored with clinical assessments and laboratory testing over a defined follow-up period to capture adverse events and measure drug levels and biological effects. Results will determine whether dosing is safe and provide early human PK/PD data to guide further development.

Who should consider this trial

Good fit: Healthy adults aged 18–45 with body weight ≥50 kg for males or ≥45 kg for females, BMI 18–28 kg/m2, able to consent and follow study procedures, and for women of childbearing potential a negative pregnancy test and agreement to use effective contraception are ideal candidates.

Not a fit: People with active autoimmune disease, those outside the age/weight/BMI ranges, pregnant or breastfeeding individuals, or those with known hypersensitivity to the drug or its excipients are unlikely to benefit from participating.

Why it matters

Potential benefit: If safe and biologically active, GenSci136 could become a new therapeutic approach for autoimmune diseases in later trials.

How similar studies have performed: Other subcutaneous biologic therapies for autoimmune conditions have shown success in later-stage trials, but GenSci136 itself is novel and is being tested in humans for the first time in this Phase 1 trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).
2. Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg/m2 (both inclusive) at screening.
3. Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening/baseline period and are not breastfeeding.
4. Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.

Exclusion Criteria:

1. Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.
2. Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.
3. A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and/or other major disease that, in the opinion of the investigator, would affect the evaluation of the study.
4. Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.
5. Positive result of alcohol breath test, or drug abuser, or use of soft drugs (such as marijuana) within 3 months prior to screening, or use of hard drugs (such as cocaine and ketamine) within 1 year prior to screening, or positive for drug screening \[including but not limited to morphine, ketamine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine\].
6. Participants judged by the investigator to be ineligible for other reasons.

Where this trial is running

Shanghai, Shanghai Municipality

• Huashan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jingsi Li

Conditions Autoimmune Disease