Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MHAA549A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MHAA4549A | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Tamiflu | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MHAA549A | DRUG | IV dose |
| Placebo | DRUG | IV dose |
| oseltamivir [Tamiflu] | DRUG | Orally b.i.d, 5 days |
Inclusion Criteria: * In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests * Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and ...
MHAA549A is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 2 influenza challenge model in healthy volunteers. It is not an approved medicine and remains in clinical development.
MHAA549A is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 2 study of the compound conducted in the United Kingdom.
MHAA549A is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA.
MHAA549A has been evaluated in one completed Phase 2 trial, NCT01980966, titled A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model. The trial enrolled 101 participants in the United Kingdom, was randomized, double-blind, and placebo-controlled.
The Phase 2 trial NCT01980966 was a randomized, double-blind, placebo-controlled study of MHAA549A in healthy volunteers aged 18 years and older in the United Kingdom. It enrolled 101 participants and has been completed. Participants were studied in an influenza challenge model.