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RECRUITING
NCT06408857
PHASE1

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

Sponsor: Gates Medical Research Institute

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

3 Months - 55 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2025-03-28

Completion Date

2026-01

Last Updated

2025-08-26

Healthy Volunteers

Yes

Interventions

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

Locations (2)

JCRC-Joint Clinical Research Centre

Kampala, Uganda

IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road

Tororo, Uganda