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.
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Number of participants reporting solicited local and systemic adverse events (AEs) in the SC cohorts
Timeframe: Through 7 days post-dose
Number of participants reporting unsolicited AEs (single dose or multiple dose)
Timeframe: Through Day 28
Number of participants reporting serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs) and adverse events special interest (AESIs)
Timeframe: Through 168 days post-dose
Number of re-dosed participants reporting SUSARs, SAEs and AESIs
Timeframe: Through 378 days
Number of participants with safety laboratory assessments by grade (grade 1 and above)
Timeframe: Up to 378 Days