Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MHAB5553A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Cohort C | EXPERIMENTAL | - |
| Cohort D | EXPERIMENTAL | - |
| Cohort E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MHAB5553A | DRUG | Single intravenous administration, at various doses, depending on the cohort |
| Matching placebo | DRUG | Single intravenous dose |
Inclusion Criteria: * Signed informed consent form (ICF) * Body mass index (BMI) between 18 and 32 kg/m2, inclusive * Weight 40-100 kg * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs * Clinical laboratory evaluations should be wi...
MHAB5553A is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, and its intended therapeutic indication has not been disclosed. It is not an approved medicine and remains in early clinical development.
MHAB5553A is developed by Roche Holding AG, which trades over the counter in the United States under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound conducted in Canada.
MHAB5553A is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.
MHAB5553A has been evaluated in one completed Phase 1 trial, NCT02528903, titled A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers. The randomized, double-blind, controlled study enrolled 26 healthy adults aged 18 and older in Canada.
The Phase 1 trial NCT02528903 was a randomized, double-blind, controlled study of MHAB5553A in healthy volunteers. It enrolled 26 participants of all sexes, aged 18 years and older, at sites in Canada, and assessed safety, tolerability, and pharmacokinetics. The trial is completed.