GenSci161 safety and how the body handles it in healthy adults

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biomarker Characteristics of a Single Subcutaneous Injection of GenSci161 Injection in Healthy Adult Participants

This trial will test whether GenSci161 is safe, well tolerated, and how it's processed by the body in healthy adults aged 18 to 45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (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: NCT07476586 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial in healthy adult volunteers designed to measure safety, tolerability, pharmacokinetics, and exploratory biomarkers after dosing with GenSci161 or placebo. Participants must meet strict weight and BMI criteria and be in good general health on screening assessments. The trial uses blinded dosing and compares active drug to placebo to characterize adverse events, blood levels over time, and biomarker changes. Results will inform dose selection and monitoring for future patient trials.

Who should consider this trial

Good fit: Healthy adults aged 18–45 with BMI 18–28 kg/m² (men ≥50 kg, women ≥45 kg), no significant medical issues on screening, and willing to follow contraception and study procedures are ideal candidates.

Not a fit: People with active medical conditions, those outside the specified age or BMI ranges, or anyone seeking direct therapeutic benefit should not expect personal clinical benefit from participation.

Why it matters

Potential benefit: If GenSci161 is shown to be safe and predictable in healthy people, the data could speed development and guide dosing for future patient trials.

How similar studies have performed: Randomized, double-blind, placebo-controlled Phase 1 safety and PK trials are a standard and successful approach for characterizing many new drugs, but GenSci161 itself is novel and untested in humans.

Eligibility criteria

Inclusion Criteria:

1. Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).
2. Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg/m² (inclusive).
3. In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory tests, and imaging examinations, with all results within reference ranges or deemed clinically insignificant by the investigator.
4. Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose. From the time of signing the ICF until 6 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female participants must have had no unprotected sexual intercourse within 14 days prior to the first dose.
5. Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.

Exclusion Criteria:

1. History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic diseases.
2. Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to screening, or planning to undergo any surgery (including cosmetic procedures) during the trial period.
3. Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic \[helminth\] infections) at any time from 4 weeks prior to screening until the day of randomization.
4. Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that may interfere with site assessment.
5. History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's judgment, could compromise the trial's conduct. This includes, but is not limited to, disorders of the following systems: neuropsychiatric, cardiovascular, urological, gastrointestinal, respiratory, musculoskeletal, metabolic, endocrine, hematologic, immunologic, and dermatologic, as well as any other major medical conditions and malignancies (with the exception of adequately treated or resected, and resolved non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin).
6. A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (TPPA), or hepatitis B virus (HBV) infection (defined as a positive hepatitis B surface antigen \[HBsAg\] and/or a positive hepatitis B core antibody \[HBcAb\] result).
7. Administration of any live or live-attenuated vaccine within 12 weeks prior to screening or planning to receive any live or live-attenuated vaccine (with the exception of inactivated influenza vaccine) during the trial period.
8. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for participation in this clinical trial.

Where this trial is running

Shanghai, Shanghai Municipality

• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: ShuQin Jiang

Conditions Healthy Volunteers