Healthy Volunteers
Conditions
Interventions
MAM01
Placebo
Sponsors
Gates MRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Acceptable 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
Exclusion criteria
Exclusion criteria: PART A & PART B • Within 48 hours prior to randomization, acute febrile illness • Sickle cell disease or history of splenectomy • Use of antimalarial chemoprevention or treatment, and/or antibiotics with known antimalarial effects (eg, clotrimoxazole, azithromycin, tetracyclines) within 30 days prior to dosing • Enrolled in another clinical trial within 90 days prior to Screening or planning to participate in another trial during, or within 1 year following, their participation in this trial • Received any doses of a malaria vaccine or other monoclonal antibodies (mAb) to Pf • Eligible to receive a malaria vaccine (RTS, S/AS01 or R21/Matrix-M) at screening or if it is expected to become available during the period of the trial. • History of allergy or hypersensitivity or contraindications to trial drugs (including those used as empirically treatment for Pf to clear any existing parasitemia), excipients or related substances • Any history of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the trial • History of any autoimmune disease or immunodeficiency or other impairment to the immune system, including HIV infection • Use of chronic (= 14 days) immunosuppressive agents including systemic steroids (eg, prednisone >10 milligrams per day [mg/day]) within 30 days prior to dosing. Use of inhaled or topical corticosteroids is permitted • Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising with blood draws • Receipt of immunoglobulins and/or blood products within the past 6 months • Any current uncontrolled medical or psychiatric condition, or substance abuse problems that in the opinion of the Investigator, will make it unlikely for participant to comply with the protocol, may interfere with study assessments, or could jeopardize the safety of the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants reporting Treatment-emergent adverse events (TEAEs);Number of participants reporting Solicited systemic AEs and solicited injection site AEs (applicable to IM dosing);Number of participants reporting serious adverse events (SAEs), adverse events of special interest (AESI), and AEs leading to discontinuation;Number of participants reporting Solicited systemic AEs and solicited injection site AEs (applicable to SC dosing) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with graded abnormal clinical hematology and chemistry laboratory results;Maximal observed blood concentration of MAM01 following the first dose (Cmax1);Concentration at Day 182 post dose (C182);Area Under the Concentration Curve (AUC) Day 0-182;Percentage of participants with antidrug antibodies (ADAs) to MAM01 through the end of trial | — |
Countries
Uganda
Contacts
Public ContactScott Miller
Clinical Development Leader
Outcome results
None listed