Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGB · 1 trial · 1 indication
Safety will be assessed throughout the study by monitoring adverse events (AEs), including their incidence, severity, and relationship to study treatment. Additional safety assessments will include clinical laboratory evaluations (hematology, clinical chemistry, and urinalysis), physical examinations, and vital sign measurements, including pulse rate, blood pressure (BP), respiration rate, and tympanic temperature.
| Arm | Type | Description |
|---|---|---|
| MGB 200 mg | EXPERIMENTAL | Participants receive MGB 200 mg administered subcutaneously once weekly on Days 1, 8, and 15 to evaluate safety, tolerability, and pharmacokinetics. |
| MGB 400 mg | EXPERIMENTAL | Participants receive MGB 400 mg administered subcutaneously once weekly on Days 1, 8, and 15 following Safety Review Committee approval. |
| MGB 600 mg | EXPERIMENTAL | Participants receive MGB 600 mg administered subcutaneously once weekly on Days 1, 8, and 15, contingent upon acceptable safety and tolerability in prior cohorts. |
| Name | Type | Description |
|---|---|---|
| MGB 200 mg | DRUG | Participants receive weekly subcutaneous administration of MGB |
| MGB 400 mg | DRUG | Participants receive an intermediate dose of MGB administered subcutaneously once weekly |
| MGB 600 mg | DRUG | Participants receive the highest planned dose of MGB administered subcutaneously |
Inclusion Criteria: 1. Healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit 2. Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to any study-related procedures being completed 3. Is in general go...