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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Huashan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jingsi Li
• Email: lijingsi@genscigroup.com
• Phone: +86 18301941524

Similar studies

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

• Remdesivir for RSV in immunocompromised adults

  This trial tests whether a short course of intravenous remdesivir can help adults whose immune systems are weakened by cellular or bispecific antibody therapies recover from upper respiratory RSV infection.

  Recruiting at 3 sites Phase 2 Fred Hutchinson Cancer Center · Duarte, California and 2 other locations · NCT06817889

• Exploring genetic factors in autoimmune and autoinflammatory diseases

  This study is trying to find out how genes affect autoimmune and autoinflammatory diseases, especially VEXAS syndrome, by looking at samples from patients with known or unknown inflammatory conditions.

  Recruiting at 2 sites NYU Langone Health · New York, New York and 1 other locations · NCT06004349

• Educational tool for melanoma patients with autoimmune diseases

  This study is testing a new educational tool to help melanoma patients with autoimmune diseases understand their treatment options better and see how easy it is for them to use.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04751396

• Using nivolumab to treat patients with autoimmune disorders and advanced cancer

  This study is testing if nivolumab can safely help people with autoimmune disorders who also have advanced cancer by looking at how well it works and what side effects it might cause.

  Recruiting at 40 sites Phase 1 National Cancer Institute (NCI) · Birmingham, Alabama and 51 other locations · NCT03816345

• Studying how genetic testing can improve medication use in patients

  This study is trying to see if using genetic testing can help doctors choose the right medications for patients with heart diseases, inflammatory bowel diseases, and autoimmune diseases to improve their treatment outcomes.

  Recruiting University of Chicago · Chicago, Illinois · NCT01280825

• Combining Rituximab and Cyclosporine for Membranous Nephropathy

  This study tests if combining two medications, rituximab and cyclosporine, can help people with membranous nephropathy improve their kidney function and reduce protein in their urine.

  Recruiting at 2 sites Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland and 1 other locations · NCT00977977

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.