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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
Bill & Melinda Gates Medical Research Institute·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
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Study focus
Disease/Condition
Malaria
Drug/Device/Intervention
MAM01
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Bill & Melinda Gates Medical Research Institute
Location
Baltimore, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jul 01, 2023
End date
Jun 01, 2025
Enrollment
61 participants
Primary outcome

Number of participants reporting solicited local and systemic adverse events (AEs) in the SC cohorts,Number of participants reporting unsolicited AEs (single dose or multiple dose),Number of participants reporting serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs) and Adverse Events Special Interest (AESIs),Number of re-dosed participants reporting SUSARs, SAEs and AESIs,Number of participants with safety laboratory assessments by grade (grade 1 and above)

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.

ICD-10 classifications
Unspecified malariaPlasmodium malariae malariaPlasmodium falciparum malariaOther parasitologically confirmed malariaPlasmodium ovale malaria
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05891236
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05891236 through Pure Global AI's free database. This Phase 1 trial is sponsored by Bill & Melinda Gates Medical Research Institute and is currently Not yet recruiting. The study focuses on Malaria. Target enrollment is 61 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.