New injection for autoimmune diseases takes first step in human testing
NCT ID NCT07366866
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new medicine called GenSci136 in 48 healthy adults in China. The goal is to check if a single shot is safe and how the body processes it. This is a first step toward possibly treating autoimmune diseases, where the immune system attacks the body.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Other studies related to the condition(s) this trial covers.
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