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

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.

Conditions

• Healthy Volunteers

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

Sponsors & Collaborators

• Gates Medical Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-28

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Uganda

Study Locations