Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5303253 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A: HV ascending dose | EXPERIMENTAL | - |
| B: HV food effect | EXPERIMENTAL | - |
| C: Hepatitis C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C) |
| RO5303253 | DRUG | Cohorts receiving single ascending doses |
Inclusion Criteria: * Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age * Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy * Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg * Fema...
RO5303253 was studied for the treatment of chronic hepatitis C, specifically genotype 1 infection. It is an investigational small molecule developed by Roche and was evaluated in a Phase 1 clinical trial that enrolled healthy volunteers and patients with chronic hepatitis C genotype 1.
RO5303253 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound in chronic hepatitis C genotype 1.
RO5303253 is in Phase 1 clinical development. It is an investigational agent and has not been approved for any indication. One Phase 1 trial has been completed, and no active trials are currently listed for this compound.
RO5303253 was evaluated in one Phase 1 trial, NCT01181024, titled a study on safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. The trial enrolled 82 participants in New Zealand and is completed.
The Phase 1 trial NCT01181024 was a randomized, double-blind, controlled study of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. It enrolled 82 participants aged 18 years and older in New Zealand and assessed safety, tolerability and pharmacokinetics.