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This study is designed to evaluate the safety, tolerability, PK and PD of GenSci120 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci120 | Experimental | Single ascending doses of GenSci120 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci120 | Drug | Administered SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | 113 days | |
| Incidence and severity of serious adverse events (SAEs) | 113 days | |
| Clinically significant changes from baseline | 113 days | |
| Concentration of GenSci120 in plasma samples. | 113 days | |
| Pharmacokinetics-AUC0-last | 113 days | |
| Pharmacokinetics-AUC0-inf | 113 days | |
| Pharmacokinetics-Tmax | 113 days | |
| Pharmacokinetics-Cmax | 113 days | |
| Pharmacokinetics-CL/F | 113 days | |
| Pharmacokinetics-t1/2 | 113 days | |
| flow cytometry | 113 days | |
| Incidence and the time of anti-drug antibody (ADA) positive and neutralizing antibody (NAb) positive (if applicable) after GenSci120 administration. |
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Inclusion Criteria:
Exclusion Criteria:
(3) History of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, neurological, respiratory, or other significant medical history that, in the investigator's opinion, may affect the assessment of this study.
(4)Severe infection, chronic infection, opportunistic infection, etc., within 3 months before screening, or systemic antimicrobial treatment for infections (including but not limited to viral, bacterial, fungal, parasitic infections) within 4 weeks prior to randomization.
(5)Use or intend to use any prescription medication to manage chronic/ongoing condition, and any acute medication use (including prescription medication, over-the-counter medication, or dietary supplements) within 14 days prior to administration.
(6)Participated in any clinical trials of investigational drugs (including investigational vaccines) and used investigational drugs within 3 months or within 5 terminal elimination half-lives (whichever is longer) prior to administration; participated in any clinical trials of medical devices within 3 months prior to screening (not including failed screening participants); currently participating in other clinical trials.
(7) Any other medical condition (at the investigator's discretion) that would impair the participant's ability to tolerate the IMP or proceed with the planned study procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 20040 | China |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Drug |
Administered SC. |
|
| 113 days |