Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VCH 916 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | VCH-916 100 mg three times a day (t.i.d.) |
| Cohort 2 | EXPERIMENTAL | VCH-916 200 mg (t.i.d.) |
| Cohort 3 | EXPERIMENTAL | VCH-916 300 mg twice daily for three days |
| cohort 4 | EXPERIMENTAL | VCH-916 400 mg twice daily for three days |
| Name | Type | Description |
|---|---|---|
| VCH 916 | DRUG | Dose escalation study with a full review of all safety data following each cohort. |
| Placebo | DRUG | Dose escalation study with a full review of all safety data following each cohort. |
Inclusion Criteria: * Males and females 18 to 60 years of age * No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3 * Subject's liver disease is stable with ALT values \< 5 X ULN * Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening * D...
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VCH 916 is an investigational small molecule being developed for the treatment of HCV infection, a chronic viral infection of the liver. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
VCH 916 is a small molecule designed to target HCV infection. The specific molecular target has not been disclosed in available information, so the exact mechanism of action is not detailed here.
VCH 916 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company listed on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
VCH 916 is in Phase 1 clinical development. It is an investigational drug and has not yet received approval from regulatory agencies. The Phase 1 trial has been completed, and the drug remains under evaluation.
VCH 916 has been studied in one completed Phase 1 clinical trial, identified as NCT00623649. This trial evaluated the safety, tolerability, and pharmacokinetics of multiple ascending doses of VCH 916 in subjects with chronic HCV infection, enrolling 42 participants.