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Clinical Trial Summary

This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria. The study will take place in parts of Africa where malaria is common. Parts A and B of the study will first test single doses of MAM01 in healthy adults, then after safety review, in older children, and then after additional safety review, in infants. Part C will then test single doses of MAM01 in children and infants who have a medical problem that could put them at greater risk if they get malaria.


Clinical Trial Description

This is a Phase 1b, age de-escalation/dose escalation trial that will be conducted in a setting of perennial high Plasmodium falciparum (malaria parasite) transmission in Africa. The study will be conducted in 3 parts: Part A (Age De-escalation/Dose Escalation in Adults and Older Children); Part B (Age De-escalation/Dose Escalation in Younger Children) and Part C (Special Pediatric Populations). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06408857
Study type Interventional
Source Bill & Melinda Gates Medical Research Institute
Contact Gates MRI
Phone +1 866 789 5767
Email clinical.trials@gatesmri.org
Status Not yet recruiting
Phase Phase 1
Start date September 2024
Completion date May 2026

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