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The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental |
| |
| Sequence B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | Receive a single dose of 240mg SHR-1314 at every period (First period:1mL AI, injection two needles. Second period: 2mL AI, injection one needle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| After a single subcutaneous injection of SHR-1314, assess injection site pain by VISUAL ANALOG SCALE at immediately after administration, 1 h, 48 h, Day 5 and Day 8, the results ranger from 0 to 10 cm, with higher scores indicating greater pain | Day 1 to Day 8 after each administration | |
| After a single subcutaneous injection of SHR-1314, the incidence rate of injection site reaction at 1 h, 48 h, Day 5 and Day 8 | Day 1 to Day 8 after each administration |
| Measure | Description | Time Frame |
|---|---|---|
| After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Time to maximum concentration (Tmax) | Day 1 to Day 28 | |
| After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Area Under the Concentration versus time curve (AUC0-t) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 300041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40947125 | Derived | Dong Y, Gao X, Feng S, Lin L, Shen K, Hu W. Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. Expert Opin Drug Metab Toxicol. 2025 Sep;21(9):1117-1123. doi: 10.1080/17425255.2025.2558829. Epub 2025 Sep 15. |
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This study is a single-center, randomized, open-label, two-period, and two-sequence crossover design trial, consisting of two sequences (sequence A and sequence B) and two periods (first period and second period). Each sequence receives a same dose of SHR-1314 at every period.
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| SHR-1314 | Drug | Receive a single dose of 240mg SHR-1314 at every period (First period:2mL AI, injection one needle. Second period: 1mL AI, injection two needles). |
|
| Day 1 to Day 28 |
| After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Maximum Concentration (Cmax) | Day 1 to Day 28 |
| Safety indicators: The rate of adverse events (AE, including Injection site reactions), serious adverse events (SAE) | Screening period up to Day 43 |
| Immunogenicity indicators: The rate of anti-SHR-1314 antibodies | Start of treatment up to Day 43 |