Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults - Trial NCT05891236
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.
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Study Focus
Sponsor & Location
Bill & Melinda Gates Medical Research Institute
Timeline & Enrollment
Phase 1
Jul 01, 2023
Jun 01, 2025
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
Data Source
ClinicalTrials.gov
NCT05891236
Non-Device Trial