Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MCAF5352A · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| MCAF5352A | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MCAF5352A | DRUG | Multiple ascending doses |
| Placebo | DRUG | Matching MCAF5352A, multiple doses |
Inclusion Criteria: * Healthy males and females, 18 - 55 years of age * Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests * Body weight between 45 kg and 110 kg * Female subjects must be willing to use two effecti...
MCAF5352A is an investigational small molecule developed by Roche Holding AG. It has been studied in Phase 1 clinical trials in healthy volunteers. No therapeutic indication has been disclosed for MCAF5352A, and it is not approved for any use.
MCAF5352A is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical trials conducted for this compound.
MCAF5352A is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The compound remains investigational and has not been approved by the FDA for any indication.
MCAF5352A has been evaluated in two completed Phase 1 trials: NCT01540760, titled A Study of MCAF5352A in Healthy Volunteers, and NCT01480310, which investigated the safety, pharmacokinetics, and immunogenicity of subcutaneous MCAF5352A in healthy volunteers. Both enrolled 23 participants in Canada.
Both Phase 1 trials of MCAF5352A were randomized, double-blind, and placebo-controlled studies in healthy volunteers aged 18 years and older. Each trial enrolled 23 participants in Canada, for a total enrollment of 46 across the two completed studies.