GenSci161 safety and how the body handles it in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: ShuQin Jiang
• Email: jiangshuqin@genscigroup.com
• Phone: +86 18036617122

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of Exercise Snacks on Muscle Size and Strength in Healthy Young Adults

  This study tests whether many small workouts throughout the week can build muscle size and improve strength in healthy, untrained young adults compared with the usual twice-weekly workouts.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT07760597

• ORX489 safety and dosing in healthy adults ages 18 to 60

  This will test whether ORX489 tablets are safe, well tolerated, and how they are processed in the body in healthy men and women aged 18 to 60.

  Recruiting Phase 1 Centessa Pharmaceuticals (UK) Limited · Lincoln, Nebraska · NCT07413666

• ReHIIT Prehabilitation in Healthy Adults

  This pilot tests a combined resistance and high‑intensity interval training program to establish baseline physiology in healthy adults before applying findings to cancer patients.

  Recruiting University of Nottingham · Derby, Derbyshire · NCT07313332

• Safety and drug levels of a 3‑month naltrexone implant (BICX104) with or without bupropion versus monthly Vivitrol injections

  This will test whether a three‑month naltrexone implant (BICX104), given alone or with extended‑release bupropion, is safe and keeps steady drug levels compared with monthly Vivitrol injections in healthy adults.

  Recruiting Phase 1 BioCorRx Pharmaceuticals Inc · Miami, Florida · NCT07269873

• Compare two forms and doses of vonafexor and see if the high dose interacts with other drugs

  This test looks at how two doses and two formulations of vonafexor (EYP651 and vonafexor acid) are absorbed and processed in healthy adults and whether the high dose interacts with common medicines.

  Recruiting Phase 1 Enyo Pharma · Gières · NCT07251153

• Low-frequency vibrating mat for sleep and daily stress recovery

  This test will see if using a low-frequency vibrating mat at home for three weeks improves stress recovery, sleep quality, mood, and attention in healthy adults aged 18-45.

  Recruiting Florida International University · Miami, Florida · NCT07221318

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.