Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05757596 | Study of VSA001 Injection in Chinese Healthy Adult Volunteers | PHASE1 | COMPLETED | 24 | — | — | May 17, 2023 | Dec 31, 2023 | Mar 20, 2025 | 1 | China |
Incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with VSA-01001. Clinically significant abnormalities in laboratory tests, vital signs, physical examination, 12-lead electrocardiograms (ECG).
| Arm | Type | Description |
|---|---|---|
| VSA001 injection | ACTIVE_COMPARATOR | A single dose of active drug (VSA001, low or high dose) will be administered by subcutaneous injection on Day 1. |
| Placebo | PLACEBO_COMPARATOR | The placebo is normal saline (0.9%) administered subcutaneously; volume matched to the corresponding VSA001 dose volume. |
| Name | Type | Description |
|---|---|---|
| VSA001 injection | DRUG | The active drug is VSA001 injection. The active pharmaceutical ingredient (API) contained in VSA001 is a synthetic, double-stranded, hepatocyte targeted NAG-conjugated RNAi. |
| Placebo | DRUG | 0.9% Saline, volume matched |
Inclusion Criteria: 1. The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with ...