NCT06408857

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

A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 3 Months – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1b, age de-escalation/dose escalation trial that will be conducted in a setting of perennial Plasmodium falciparum (malaria parasite) transmission in Africa. The study will be conducted in 2 parts: Part A (Dose Escalation in Adults); Part B (Age De-escalation/Dose Escalation in Younger Children and infants).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MAM01 300 mg SC	MAM01 300 mg will be administered SC
DRUG	MAM01 300 mg IM	MAM01 300 mg will be administered IM route
DRUG	MAM01 2000 mg IV	MAM01 2000 mg will be administered IV
DRUG	MAM01 190 mg SC	MAM01 190 mg will be administered SC
DRUG	MAM01 225 mg SC	MAM01 225 mg will be administered SC
DRUG	MAM01 150 mg SC	MAM01 150 mg will be administered SC
DRUG	MAM01 150 mg IM	MAM01 150 mg will be administered IM
DRUG	MAM01 150 mg IV	MAM01 150 mg will be administered IV
DRUG	Placebo SC	Placebo will be administered SC
DRUG	Placebo IV	Placebo will be administered IV.
DRUG	Placebo IM	Placebo will be administered IM

Timeline

• Start date: 2025-03-28
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-05-10
• Last updated: 2025-08-26

Locations

2 sites across 1 country: Uganda