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Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
Sponsor: Gates Medical Research Institute
Summary
This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). This study will evaluate the safety, tolerability, pharmacokinetics (PK), and protective efficacy of MAM01, as well as safety and PK of repeat subcutaneous (SC) dosing. Part A will have a double-blind, placebo-controlled design. Part B will randomize participants to one of three open-label MAM01 dose groups; a separate non-randomized group will be enrolled to include participants who will receive no treatment and act as infectivity controls.
Official title: A Phase 1, Dose Escalation, Double Blind, Placebo Controlled Clinical Trial With Controlled Human Malaria Infections (CHMI) to Evaluate Safety, Tolerability, Pharmacokinetics, and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, MAM01, in Healthy, Malaria-Naive Adults
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2023-08-14
Completion Date
2024-12-13
Last Updated
2026-06-12
Healthy Volunteers
Yes
Conditions
Interventions
MAM01 1.5 mg/kg
1.5 mg/kg MAM01 will be administered via IV route.
Placebo
Placebo will be administered via IV route.
MAM01 5 mg/kg
5 mg/kg MAM01 will be administered via SC route.
MAM01 10 mg/kg
10 mg/kg MAM01 will be administered via IV route.
MAM01 40 mg/kg
40 mg/kg MAM01 will be administered via IV route.
MAM01 450 mg
MAM01 will be administered via SC route.
Placebo
Placebo will be administered via SC route.
MAM01 5 mg/kg
5 mg/kg MAM01 will be administered via IV route.
Control
No drug or placebo will be administered.
MAM01 600 mg
MAM01 will be administered via SC route.
MAM01 900 mg
MAM01 will be administered via SC route.
Locations (1)
Center for Vaccine Development and Global Health, 685 W. Baltimore Street
Baltimore, Maryland, United States