Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5271983- MAD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo - MAD | DRUG | Once or twice daily doses of matching placebo to RO5271983 for 14 days |
| Placebo - SAD | DRUG | Single dose of matching placebo to RO5271983 for up to 3 periods |
| RO5271983 - MAD | DRUG | Once or twice daily doses of RO5271983 for 14 days |
| RO5271983 - SAD | DRUG | Single dose of RO5271983 at each period (for up to 3 periods) |
Inclusion Criteria: * Healthy volunteers, 18-65 years of age * Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive * In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of high...
RO5271983- MAD is an investigational small molecule drug developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy volunteers. The multiple ascending dose (MAD) portion of the study evaluated the drug's safety and tolerability. The specific therapeutic indication for RO5271983- MAD has not been disclosed.
RO5271983- MAD is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is a Swiss multinational healthcare company. The drug is currently in Phase 1 clinical development.
RO5271983- MAD is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy volunteers. As an investigational drug, it has not been approved by the FDA or any regulatory agency for any indication.
RO5271983- MAD has been studied in one clinical trial: NCT01209221, titled "A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers." This Phase 1 trial was completed and enrolled 82 participants in New Zealand. It was randomized, placebo-controlled, and included healthy volunteers.
Yes, RO5271983- MAD is also known as RO5271983 - MAD. The two names refer to the same investigational drug candidate developed by Roche Holding AG. The slight difference in spacing is a formatting variation.