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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety, tolerability, and pharmacokinetics. It is not approved for any indication and remains in early-stage clinical research.
MHAB5553A is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule in healthy volunteers.
MHAB5553A is in Phase 1 clinical development. A single Phase 1 trial has been completed, which studied the drug in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
MHAB5553A has one completed clinical trial, NCT02528903, titled 'A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers.' This Phase 1 study enrolled 26 participants in Canada and was randomized, double-blind, and controlled.
MHAB5553A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a Phase 1 study in healthy volunteers, and the drug has not progressed to later-stage trials or regulatory submission.