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This is a first-in-human, phase 1, single-center, randomized, double blinded, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, of 608 following subcutaneous injection in healthy subjects.
The study will consist of a 14-days screening period (-14~-1 days); an observation period (7-14 days) and the follow-up period (71-91days); Subjects will be randomly assigned to seven group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 608 | Experimental | 8mg, 20mg, 40mg, 80mg, 120mg, 160mg, 200mg |
|
| Placebo | Placebo Comparator | 20mg, 40mg, 80mg, 120mg, 160mg, 200mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 608 | Drug | recombinant humanized anti-IL17A monoclonal antibody injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AE/SAEs | Incidence of treatment emergent AE/SAEs | From baseline through overall study (follow-up period: the arm of 8mg, 20mg,40mg with 71 days; 80mg, 120mg,160mg, 200mg with 91 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration (Cmax) of 608 | From baseline through 71days/91day |
| Tmax | Time to Reach the Maximum Concentration After Drug Administration (Tmax) in 608 group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhou Lu, PhD | Contact | (021)37990333-5278 | luhongzhou@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Clinical Center (Shanghai) | Recruiting | Jinshan | Shanghai Municipality | 201508 | China |
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| Placebo |
| Drug |
auxiliary material of 608 include histidine, histidine hydrochloride, sucrose and polysorbate 80 |
|
| From baseline through 71days/91day |
| AUClast | Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast) in 608 group. | From baseline through 71days/91day |
| AUCinf | Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in 608 group. | From baseline through 71days/91day |
| CL | Systemic Clearance From Serum Following Intravenous Administration (CL) in 608 group | From baseline through 71days/91day |
| Vd | Apparent volume of distribution (Vd) in 608 group | From baseline through 71days/91day |
| T1/2 | Terminal Elimination Half-life (T1/2) in 608 group | From baseline through 71days/91day |
| MRT | Mean residence time (MRT) in 608 group | From baseline through 71days/91day |
| λz | Apparent terminal elimination rate constant (λz)in 608 group. | From baseline through 71days/91day |
| Percentage of Participants With Anti-608 Antibodies | Percentage of participants with treatment-emergent positive anti-608 antibodies and Neutralizing antibody; | From baseline through 71days/91day. |