NCT05891236

Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	MAM01 1.5 mg/kg	1.5 mg/kg MAM01 will be administered via IV route.
BIOLOGICAL	Placebo	Placebo will be administered via IV route.
BIOLOGICAL	MAM01 5 mg/kg	5 mg/kg MAM01 will be administered via SC route.
BIOLOGICAL	MAM01 10 mg/kg	10 mg/kg MAM01 will be administered via IV route.
BIOLOGICAL	MAM01 40 mg/kg	40 mg/kg MAM01 will be administered via IV route.
BIOLOGICAL	MAM01 450 mg	MAM01 will be administered via SC route.
BIOLOGICAL	Placebo	Placebo will be administered via SC route.
BIOLOGICAL	MAM01 5 mg/kg	5 mg/kg MAM01 will be administered via IV route.
OTHER	Control	No drug or placebo will be administered.
BIOLOGICAL	MAM01 600 mg	MAM01 will be administered via SC route.
BIOLOGICAL	MAM01 900 mg	MAM01 will be administered via SC route.

Timeline

• Start date: 2023-08-14
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2023-06-06
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study