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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3383 in healthy subjects. The study will be designed as a single ascending dose (SAD) phase, utilizing a double-blind, placebo-controlled approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGB-3383 | Experimental | SGB-3383 for sc injection |
|
| SGB-3383-Matching placebo | Placebo Comparator | Normal saline (0.9% NaCl) matching volume of SGB-3383 doses will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGB-3383 | Drug | SGB-3383 for sc injection, single dose |
| |
| SGB-3383-Matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of SGB-3383 | Up to Day 3 | |
| Area Under the Concentration-time Curve (AUC) of SGB-3383 | Up to Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SGB.clinical | Contact | +086 021-60209828 | SGB.clinical@sanegenebio.com |
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| Drug |
SC injection, single dose |
|