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This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental |
| |
| Dose 2 | Experimental |
| |
| Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5965 capsule | Drug | HRS-5965 capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subjects with adverse events (AEs) | Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation. | Baseline up to seven days after the last dosing. |
| QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules | Baseline up to 24 hours after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for HRS-5965 | Baseline up to seven days after the last dosing. | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for HRS-5965 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
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| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| HRS-5965 capsule placebo |
| Drug |
HRS-5965 capsule placebo |
|
| Baseline up to seven days after the last dosing. |
| Maximum plasma concentration (Cmax) for HRS-5965 | Baseline up to seven days after the last dosing. |
| Time to reach maximum plasma concentration (Tmax) for HRS-5965 | Baseline up to seven days after the last dosing. |
| Terminal half-life (t1/2) for HRS-5965 | Baseline up to seven days after the last dosing. |
| Apparent clearance (CL/F) of HRS-5965 for administration subcutaneously | Baseline up to seven days after the last dosing. |
| Apparent volume of distribution (V/F) of HRS-5965 for administration subcutaneously | Baseline up to seven days after the last dosing. |
| Complement system alternative pathway (AP) inhibition efficiency | Baseline up to seven days after the last dosing. |