A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission
This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria for at least 4 months. The study will take place in parts of Africa where malaria is common. Part A is an open-label study conducted in healthy adults whereas Part B is double-blind study conducted in young children and infants. Both the parts will evaluate the safety, tolerability and pharmacokinetics of MAM01.
⁃ PART A
• Male or female adults aged 18 to 55 years inclusive at the time of signing the informed consent form (ICF), who are capable of, and willing to provide, informed consent
• Healthy, as determined by Investigator assessment, including medical history, physical examination, and screening laboratory results
• All dosing groups: hemoglobin level ≥ 8 grams per deciliter (g/dL)
• All dosing groups: living within local jurisdiction of trial site(s) and available for the duration of the trial for all cohorts
• Female participants of childbearing potential must be nonpregnant and agree to avoid becoming pregnant by using an acceptable contraception method
⁃ PART B
• Age Cohort 2: male or female children aged 2 years to \<5 years at the time their parent or Legally Authorized Representative (LAR) signs the ICF
• Age Cohort 3: male or female children aged 12 months to \<24 months at the time their parent or LAR signs the ICF
• Age Cohort 4: male or female infant children aged 3 months to \<12 months and weighing at least 5 kilograms (kg) at the time their parent or LAR signs the ICF
• Healthy, as determined by Investigator assessment, including medical history, physical examination, and screening laboratory results
• Hemoglobin level ≥ 8g/dL
• Height and weight Z-scores ≥-2
• Living within local jurisdiction of trial site(s) and available for the duration of the trial