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

Malaria Clinical Trial

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

Clinical Trial Summary

This is a First-in-Human (FiH) double-blind, randomized, placebo-controlled, 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05891236
Study type Interventional
Source Bill & Melinda Gates Medical Research Institute
Contact Gates MRI
Phone +1 857 702 2108
Email clinical.trials@gatesmri.org
Status Recruiting
Phase Phase 1
Start date August 14, 2023
Completion date June 2025
View Details
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