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The Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1894 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1894 Injection Group | Experimental | SHR-1894 injection, in different doses. |
|
| SHR-1894 Injection Placebo Group | Placebo Comparator | SHR-1894 injection placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1894 Injection | Drug | SHR-1894 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Any changes in adverse events (AEs) | Safety and tolerability, including any changes in adverse events (AEs), 12-lead electrocardiograms (ECGs), vital signs, physical examinations, laboratory findings, and other relevant parameters. | Up to Day 85. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of SHR-1894 in serum following single subcutaneous administration | Pharmacokinetics (PK) endpoint. | Up to Day 85. |
| Maximum observed plasma concentration of SHR-1894 (Cmax) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruifang Guan | Contact | +86-0518-81220121 | ruifang.guan.rg1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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A randomized, double-blind, placebo-controlled study.
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| SHR-1894 Injection Placebo |
| Drug |
SHR-1894 injection placebo. |
|
| Up to Day 85. |
| Time to Cmax (Tmax) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. | Up to Day 85. |
| Area under the concentration-time curve from 0 to the last measurable time point after SHR-1894 administration (AUC0-t) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. | Up to Day 85. |
| Area under the concentration-time curve from time 0 to infinity after SHR-1894 administration (AUC0-inf) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. | Up to Day 85. |
| Apparent clearance of SHR-1894 (CL/F) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. | Up to Day 85. |
| Apparent volume of distribution of SHR-1894 (Vz/F) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. | Up to Day 85. |
| Terminal elimination half-life of SHR-1894 (t1/2) | Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration. | Up to Day 85. |
| Incidence of Anti-drug Antibodies (ADA) | Including positive rate and duration. | Up to Day 85. |