NCT07366866 A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.
| NCT ID | NCT07366866 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Condition | Autoimmune Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-02-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-03-16 with a primary completion date of 2027-02-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07366866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Autoimmune Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07366866 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07366866 currently recruiting?
Yes, NCT07366866 is actively recruiting participants. Contact the research team at lijingsi@genscigroup.com for enrollment information.
Where is the NCT07366866 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07366866 clinical trial?
NCT07366866 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. The trial plans to enroll 48 participants.