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This study is a randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768 in healthy volunteers. The purpose is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768.
It is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768. The primary objective is to evaluate the safety, tolerability of SGB-9768 when administered subcutaneously as a single dose to healthy volunteers. The secondary objective is to characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGB-9768 | Experimental | a single dose of SGB-9768 by subcutaneous (sc) injection |
|
| Placebo | Placebo Comparator | placebo calculated volume to match active treatment by sc injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGB-9768 | Drug | SGB-9768 for sc injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SGB-9768 | Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | 169 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-Cmax | Maximum Observed Plasma Concentration (Cmax) | 48 hours |
| Pharmacokinetics-Tmax | Time at which the maximum plasma concentration (Cmax) occurs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital | Shanghai | China |
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| Other |
sterile normal saline (0.9% NaCl) for sc injection |
|
| 48 hours |
| Pharmacokinetics-AUClast | Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration | 48 hours |
| Pharmacokinetics-AUCinf | Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf) | 48 hours |
| Pharmacokinetics-t1/2 | Terminal Elimination Half-Life (t1/2) | 48 hours |
| Pharmacokinetics-CL/F | Total Body Clearance | 48 hours |
| Pharmacokinetics-Vz/F | Volume of Distribution (Vz/F) | 48 hours |
| Pharmacodynamics-C3 | Change From Baseline in Complement 3 (C3) | 169 days |
| Pharmacodynamics-complement acitvity | Change From Baseline in Complement Activity | 169 days |