Healthy Volunteers Clinical Trial
Official title:
A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MAM01 in Adults, Children, and Special Pediatric Populations in a Setting of Perennial Malaria Transmission in Africa
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.
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). ;
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