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NCT06408857

Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population

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
Bill & Melinda Gates Medical Research Institute·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
MAM01 300 mg SC
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bill & Melinda Gates Medical Research Institute
Location
Kisumu,Busia,Kampala,Tororo, Kenya,Uganda
Timeline & enrollment
Phase
Phase 1
Start date
Sep 01, 2024
End date
May 01, 2026
Enrollment
264 participants
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
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06408857
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.