Phase
Condition
Healthy Volunteers
Treatment
Placebo IM
MAM01 75 mg SC
MAM01 190 mg SC
Clinical Study ID
Ages 3-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
PART A
Male or female adults aged 18 to 55 years inclusive at the time of signing theinformed consent form (ICF), who are capable of, and willing to provide, informedconsent
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 availablefor the duration of the trial for all cohorts
Female participants of childbearing potential must be nonpregnant and agree to avoidbecoming 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 theirparent or Legally Authorized Representative (LAR) signs the ICF
Age Cohort 3: male or female children aged 12 months to <24 months at the time theirparent or LAR signs the ICF
Age Cohort 4: male or female infant children aged 3 months to <12 months andweighing 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 ofthe trial
Exclusion
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 knownantimalarial effects (eg, clotrimoxazole, azithromycin, tetracyclines) within 30 days prior to dosing
Enrolled in another clinical trial within 90 days prior to Screening orplanning 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) toPf
Eligible to receive a malaria vaccine (RTS, S/AS01 or R21/Matrix-M) atscreening or if it is expected to become available during the period of thetrial.
History of allergy or hypersensitivity or contraindications to trial drugs (including those used as empirically treatment for Pf to clear any existingparasitemia), 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 recurrenceduring the trial
History of any autoimmune disease or immunodeficiency or other impairment tothe 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 todosing. 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 bruisingwith blood draws
Receipt of immunoglobulins and/or blood products within the past 6 months
Any current uncontrolled medical or psychiatric condition, or substance abuseproblems that in the opinion of the Investigator, will make it unlikely forparticipant to comply with the protocol, may interfere with study assessments,or could jeopardize the safety of the participant
Any contraindication for a subcutaneous injection, intravenous injection, orintramuscular injection, as applicable
For Part A female participants who are breastfeeding, pregnant, or unable orunwilling to adhere to required contraception
For Part B, in the opinion of the Investigator, the parent or LAR may not beable to ensure participant compliance with the requirements of the trial
Study Design
Study Description
Connect with a study center
KEMRI CGRH, Kenya
Kisumu, 40100
KenyaSite Not Available
IDRC-Infectious Disease Research Collaboration, IDRC Masafu General Hospital Manjanji Road
Busia,
UgandaSite Not Available
JCRC-Joint Clinical Research Centre
Kampala, 10005
UgandaActive - Recruiting
IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road
Tororo, 749
UgandaActive - Recruiting
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