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 being studied in healthy volunteers. It is in Phase 1 clinical development, with two completed trials in Canada that enrolled a total of 46 participants. The drug is not approved and remains under investigation for safety, pharmacokinetics, and immunogenicity.
MCAF5352A is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteers.
MCAF5352A is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in healthy volunteers in Canada. The drug is investigational and has not been approved for any use.
MCAF5352A has two completed Phase 1 trials: NCT01480310, a study of safety, pharmacokinetics, and immunogenicity of subcutaneous MCAF5352A in healthy volunteers, and NCT01540760, a study of MCAF5352A in healthy volunteers. Both enrolled 23 participants each in Canada.
MCAF5352A is not FDA approved. It is an investigational drug in Phase 1 clinical development, with completed trials in healthy volunteers. No approval status has been established, and the drug remains under clinical investigation.