At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating MAM01 1.5 mg/kg, Placebo, and 7 other interventions for Malaria. Completed, enrolled 63 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
2 sentinel participants will be randomized in a 1:1 ratio to receive MAM01 1.5 milligrams per kilogram (mg/kg) IV or placebo. Following at least a 24-hour safety review period, the 6 remaining participants of Cohort 1 will be randomized in a 5:1 ratio to receive MAM01 1.5 mg/kg IV or placebo.
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 5 mg/kg SC or placebo
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 5 mg/kg IV or placebo.
8 participants will be randomly assigned in a 6:2 ratio to receive MAM01 10 mg/kg IV or placebo.
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 40 mg/kg IV or placebo
Participants from Cohort 2 and from Cohort 3 will receive 5 mg/kg MAM01 SC.
6 participants will receive a 450 mg SC dose of MAM01. The dose was selected by applying a PK-pharmacodynamic (PD) model from the Part A data to estimate a (data-driven) protection threshold at Controlled Human Malaria Infection (CHMI).
8 participants will receive a 600 mg SC dose of MAM01. The dose was selected by applying a PK-PD model from the Part A data to estimate a (data-driven) protection threshold at CHMI
8 participants will receive 900 mg SC dose of MAM01. The dose was selected by applying a PK-PD model from the Part A data to estimate a (data-driven) protection threshold at CHMI.
6 participants will be enrolled into a non-randomized group prior to CHMI. These participants will receive no treatment and act as infectivity controls
Interventions
1.5 mg/kg MAM01 will be administered via IV route.
Placebo will be administered via IV route.
5 mg/kg MAM01 will be administered via SC route.
10 mg/kg MAM01 will be administered via IV route.
40 mg/kg MAM01 will be administered via IV route.
MAM01 will be administered via SC route.
Placebo will be administered via SC route.
5 mg/kg MAM01 will be administered via IV route.
No drug or placebo will be administered.
MAM01 will be administered via SC route.
MAM01 will be administered via SC route.