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To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci0161 | Experimental | Single ascending doses of GenSci161 administered subcutaneous injection |
|
| Placebo | Placebo Comparator | All subjects will receive matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci161 | Drug | Administered subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures | Day1- Day183 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from zero up to a definite time t (AUC0-t) | Day1- Day183 | |
| Area under the concentration-time curve from zero up to infinity (AUC0-∞) | Day1- Day183 | |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of IL-6 and IL-8 and their changes from baseline | Day1- Day183 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ShuQin Jiang | Contact | +86 18036617122 | jiangshuqin@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Drug |
Administered subcutaneous injection |
|
| Maximum concentration (Cmax) |
| Day1- Day183 |
| Terminal elimination half-life (t1/2) | Day1- Day183 |
| Apparent clearance (CL/F) | Day1- Day183 |
| Apparent volume of distribution (Vd/F) | Day1- Day183 |
| Anti-drug antibody (ADA) and neutralizing antibody(Nab) | Day1- Day183 |
| Upper limit of the two-sided 90% confidence interval for ∆∆QTcF corresponding to the maximum geometric mean of Cmax obtained from the study | Day1- Day15 |