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This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2061 group | Experimental | Subjects in experimental group will receive a single subcutaneous injection of SYH2061 on Day 1. |
|
| Placebo group | Placebo Comparator | Subjects in placebo group will receive a single subcutaneous injection of placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2061 | Drug | subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events as Assessed by CTCAE v5.0 | To assess the safety and tolerability of SYH2061 in healthy subjects | Up to Day 337 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of SYH2061 | To characterize the Cmax of SYH2061 in healthy subjects | Up to 72 hours post-dose |
| Time to maximum observed plasma concentration (Tmax) of SYH2061 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | +86-0311-69085587 | ctr-contact@cspc.cn | |
| Wei Hu | Contact | 13856086475 | huwei@ahmu.edu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
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| Drug |
subcutaneous injection |
|
To characterize the Tmax of SYH2061 in healthy subjects
| Up to 72 hours post-dose |
| Area under the concentration-curve from zero to the last quantifiable concentration (AUClast) of SYH2061 | To characterize the AUClast of SYH2061 in healthy subjects | Up to 72 hours post-dose |
| Area under the concentration-time curve from zero to infinity (AUCinf) of SYH2061 | To characterize the AUCinf of SYH2061 in healthy subjects | Up to 72 hours post-dose |
| Terminal elimination half-life (t1/2) of SYH2061 | To characterize the t1/2 of SYH2061 in healthy subjects | Up to 72 hours post-dose |
| Apparent clearance (CL/F) of SYH2061 | To characterize the CL/F of SYH2061 in healthy subjects | Up to 72 hours post-dose |
| Apparent volume of distribution (Vz/F) of SYH2061 | To characterize the Vz/F of SYH2061 in healthy subjects | Up to 72 hours post-dose |
| Percent change from baseline in complement C5 and its fragments C5a and C5b-9 | To assess the PD effects of SYH2061 in healthy subjects | Up to Day 337 |
| Percent change from baseline in complement alternative pathway (CAP) | To assess the PD effects of SYH2061 in healthy subjects | Up to Day 337 |
| Percent change from baseline in complement classical pathway (CCP) | To assess the PD effects of SYH2061 in healthy subjects | Up to Day 337 |
| Incidence of ADA | To assess the immunogenicity of SYH2061 in healthy subjects | Day85 |