Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci136 | Experimental | Single ascending doses of GenSci136 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci136 | Drug | Administered SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs) | Day1-Day113 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of free GenSci136/total GenSci136 | Serum concentrations at different time points will be listed and summarized by descriptive statistics. | Day1-Day113 |
| Maximum serum concentration (Cmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingsi Li | Contact | +86 18301941524 | lijingsi@genscigroup.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
Not provided
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered SC. |
|
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
| Day1-Day113 |
| Time to maximum serum concentration (Tmax) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above. | Day1-Day113 |
| Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above. | Day1-Day113 |
| Area under concentration-time from time zero to infinity (AUC0-inf) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above. | Day1-Day113 |
| Terminal elimination half-life (t1/2) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above. | Day1-Day113 |
| Clearance (CL/F) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above. | Day1-Day113 |
| Apparent volume of distribution (Vd/F) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above. | Day1-Day113 |
| ● Changes from baseline in free and total a proliferation inducing ligand (APRIL) levels; ● Changes from baseline in free and total B-cell activating factor (BAFF) levels. | Day1-Day113 |
| Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration. | Day1-Day113 |