Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MHAA4549A · 4 trials · 3 indications
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.
The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.
| Arm | Type | Description |
|---|---|---|
| MHAA4549A 3600 milligrams (mg) | EXPERIMENTAL | Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration. |
| MHAA4549A 8400 mg | EXPERIMENTAL | Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive single-dose placebo by IV administration. |
| A: MHAA4549A 3600 mg + Oseltamivir | EXPERIMENTAL | Participants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days. |
| B: MHAA4549A 8400 mg + Oseltamivir | EXPERIMENTAL | Participants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days. |
| C: Placebo + Oseltamivir | PLACEBO_COMPARATOR | Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy (75 or 150 mg BID) for minimum of 5 days. |
| MHAA4549A higher dose | EXPERIMENTAL | - |
| MHAA4549A lower dose | EXPERIMENTAL | - |
| MHAA4549A Arm | EXPERIMENTAL | - |
| Placebo Arm | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MHAA4549A | DRUG | MHAA4549A will be administered as a single dose by IV administration. |
| Placebo | DRUG | Placebo will be administered as a single dose by IV administration. |
| Oseltamivir | DRUG | Participants will receive oseltamivir capsule either 75 mg or 150 mg BID orally for minimum of 5 days. Dosage and administration should follow local prescribing information for oseltamivir. |
Inclusion Criteria: * Otherwise healthy participants * Positive test for influenza A infection * No more than 72 hours elapsed between onset of influenza-like illness and start of study drug * Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chill...
MHAA4549A is an investigational drug being studied for the treatment of Influenza A and Influenza. It has been evaluated in clinical trials involving healthy volunteers and participants with severe Influenza A infection, as well as in otherwise healthy adults with acute uncomplicated seasonal Influenza A.
MHAA4549A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug across multiple countries, including Canada, the United States, and various European and Asian nations.
MHAA4549A is in Phase 2 clinical development. It has completed Phase 1 trials in healthy volunteers and Phase 2 trials in patients with Influenza A infection. The drug remains investigational and has not been approved by regulatory authorities.
MHAA4549A has been studied in four completed clinical trials. These include NCT01877785 and NCT02284607, which assessed safety and pharmacokinetics in healthy volunteers, and NCT02293863 and NCT02623322, which evaluated the drug in patients with Influenza A infection.
No, MHAA4549A is not the same as oseltamivir. In one clinical trial, NCT02293863, MHAA4549A was studied in combination with oseltamivir versus oseltamivir alone in participants with severe Influenza A infection, indicating they are distinct treatments being tested together.
MHAA4549A is a small molecule drug, but its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its effects on Influenza A and Influenza infections, though the exact mechanism of action is not specified.