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 is an investigational small molecule being studied for the treatment of chronic hepatitis C and for use in healthy volunteers. It was evaluated in a Phase 1 clinical trial that included patients with chronic hepatitis C genotype 1 and healthy volunteers.
RO5303253 is a small molecule, but its specific molecular target has not been disclosed. The drug was studied for its safety, tolerability, and pharmacokinetics in healthy volunteers and patients with chronic hepatitis C genotype 1.
RO5303253 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored a Phase 1 clinical trial of the drug in New Zealand.
RO5303253 is in Phase 1 clinical development. It has completed one Phase 1 trial, and the drug remains investigational and is not approved for any use.
RO5303253 has one completed Phase 1 trial, NCT01181024, which studied its safety, tolerability, and pharmacokinetics in healthy volunteers and patients with chronic hepatitis C genotype 1. The trial enrolled 82 participants in New Zealand.
RO5303253 is not known to have any alternative names. It is identified by its code name RO5303253 and was studied as a single investigational agent in clinical trials.