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

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

August 14, 2023

Primary Completion Date

December 13, 2024

Study Completion Date

December 13, 2024

Conditions
Malaria
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.

Trial Locations (1)

21201

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

All Listed Sponsors
lead

Gates Medical Research Institute

OTHER