Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VSA001 · 1 trial · 1 indication
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 ...
VSA001 is an investigational small molecule being studied for use in healthy adult volunteers. It is currently in Phase 1 clinical development, with a completed trial in Chinese healthy adult volunteers. The drug is not approved and remains in clinical testing.
VSA001 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARWR. The company is conducting clinical research on this investigational small molecule in healthy adult volunteers.
VSA001 is in Phase 1 clinical development. A Phase 1 study in healthy adult volunteers has been completed. The drug is investigational and has not been approved for any use, as it is still in early-stage clinical testing.
VSA001 has one completed clinical trial, NCT05757596, titled 'Study of VSA001 Injection in Chinese Healthy Adult Volunteers.' This Phase 1 study enrolled 24 participants in China, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
VSA001 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only known trial, NCT05757596, has been completed, but the drug remains in clinical testing and has not received regulatory approval.