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COMPLETED
NCT05891236
PHASE1

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

Sponsor: Gates Medical Research Institute

View on ClinicalTrials.gov

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

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.

Locations (1)

Center for Vaccine Development and Global Health, 685 W. Baltimore Street

Baltimore, Maryland, United States