drugset / Trial / NCT06408857
Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria for at least 4 months. The study will take place in parts of Africa where malaria is common. Part A is an open-label study conducted in healthy adults whereas Part B is double-blind study conducted in young children and infants. Both the parts will evaluate the safety, tolerability and pharmacokinetics of MAM01.
Timeline
- Start
- 2025-03-28
- Primary completion
- 2026-05-28
- Completion
- 2026-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MAM01 | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | MAM01 | Monoclonal antibody | 190 mg | Subcutaneous |
| Subject | MAM01 | Monoclonal antibody | 225 mg | Subcutaneous |
| Subject | MAM01 | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | MAM01 | Monoclonal antibody | 2000 mg | Subcutaneous |
Indications
No indication recorded.