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.
This is a Phase 1b, age de-escalation/dose escalation trial that will be conducted in a setting of perennial Plasmodium falciparum (malaria parasite) transmission in Africa. The study will be conducted in 2 parts: Part A (Dose Escalation in Adults); Part B (Age De-escalation/Dose Escalation in Younger Children and infants).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
MAM01 300 mg will be administered SC
MAM01 300 mg will be administered IM route
MAM01 2000 mg will be administered IV
JCRC-Joint Clinical Research Centre
Kampala, Uganda
IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road
Tororo, Uganda
Number of participants reporting Treatment-emergent adverse events (TEAEs)
Time frame: Up to 28 days post dose (Part A and B)
Number of participants reporting serious adverse events (SAEs), adverse events of special interest (AESI), and AEs leading to discontinuation
Time frame: Up to 182 days post dose
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to IM dosing)
Time frame: Up to 7 days post dose
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to SC dosing)
Time frame: Up to 7 days post dose
Percentage of participants with graded abnormal clinical hematology and chemistry laboratory results
Time frame: Up to 28 days post dose
Maximal observed blood concentration of MAM01 following the first dose (Cmax1)
Capillary blood samples will be collected for the analysis pharmacokinetic parameters. Blood concentrations of MAM01 will be measured using a validated immunoassay.
Time frame: Pre- and post-dose (IV dosing groups only) at Day 1, 4, 7, 14, 28, 56, 84, 112, 140, and 182
Concentration at Day 182 (C182)
Time frame: At Day 182 post first dose
Total Area Under the Concentration Curve (AUC) Day 0 - Day 182
Time frame: From 0 to 182 days post dose
Percentage of participants with antidrug antibodies (ADAs) to MAM01
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MAM01 190 mg will be administered SC
MAM01 225 mg will be administered SC
MAM01 150 mg will be administered SC
MAM01 150 mg will be administered IM
MAM01 150 mg will be administered IV
Placebo will be administered SC
Placebo will be administered IV.
Placebo will be administered IM
Time frame: At Days 1, 28, 84, and 182