Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population - Trial NCT06408857
Access comprehensive clinical trial information for NCT06408857 through Pure Global AI's free database. This Phase 1 trial is sponsored by Bill & Melinda Gates Medical Research Institute and is currently Not yet recruiting. The study focuses on Healthy Volunteers. Target enrollment is 264 participants.
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Study Focus
Sponsor & Location
Bill & Melinda Gates Medical Research Institute
Timeline & Enrollment
Phase 1
Sep 01, 2024
May 01, 2026
Primary Outcome
Number of participants reporting Treatment-emergent adverse events (TEAEs),Number of participants reporting serious adverse events (SAEs), adverse events of special interest (AESI), and AEs leading to discontinuation,Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to IM dosing),Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to SC dosing)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06408857
Non-Device Trial