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

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

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.

Sponsors & Collaborators

• Gates Medical Research Institute

  lead OTHER

Principal Investigators

• +1 866 789 5767 · Gates Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-14

Primary Completion

2024-12-13

Completion

2024-12-13

FDA Drug

Yes

Countries

• United States

Study Locations