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This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci120 | Experimental | Multiple ascending doses of GenSci120 administered subcutaneously (SC). |
|
| Placebo | Experimental | Multiple ascending doses of placebo administered subcutaneously (SC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci120 | Drug | a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level |
|
| Measure | Description | Time Frame |
|---|---|---|
| TEAEs | Incidence and severity of treatment-emergent adverse events | 169 days |
| SAEs | Incidence and severity of serious adverse events | 169 days |
| CSfadf | Clinically significant changes from baseline | 169 days |
| Measure | Description | Time Frame |
|---|---|---|
| plasma | Concentration of GenSci120 in plasma samples. | 169 days |
| AUC0-t, AUC0-∞ | Area under drug concentration-time curve | 169 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiting Chi, Master | Contact | +86 13482779422 | chiyiting@genscigroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang, M.D. | Huashan Hospital | Principal Investigator |
| Xiaojie Wu, M.D. | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Placebo | Drug | a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level |
|
| Tmax | time to maximum concentration | 169 days |
| Cmax | maximum concentration | 169 days |
| t1/2 | 169 days | half-life |
| CL/F | 169 days | apparent clearance |
| V/F | apparent volume of distribution | 169 days |
| RO of T cell subset | Receptor occupancy (RO) of T cell subset detected by flow cytometry | 169 days |
| cell counts of T cell subset | cell counts of T cell subset detected by flow cytometry | 169 days |
| Incidence of ADA | Incidence of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration | 169 days |
| Time of ADA | Time of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration | 169 days |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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