Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population

Last updated: April 7, 2025
Sponsor: Bill & Melinda Gates Medical Research Institute
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo IM

MAM01 75 mg SC

MAM01 190 mg SC

Clinical Study ID

NCT06408857
Gates MRI-MAM01-103
  • Ages 3-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

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

Total Participants: 139
Treatment Group(s): 16
Primary Treatment: Placebo IM
Phase: 1
Study Start date:
April 01, 2025
Estimated Completion Date:
January 31, 2026

Study Description

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).

Connect with a study center

  • KEMRI CGRH, Kenya

    Kisumu, 40100
    Kenya

    Site Not Available

  • IDRC-Infectious Disease Research Collaboration, IDRC Masafu General Hospital Manjanji Road

    Busia,
    Uganda

    Site Not Available

  • JCRC-Joint Clinical Research Centre

    Kampala, 10005
    Uganda

    Active - Recruiting

  • IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road

    Tororo, 749
    Uganda

    Active - Recruiting

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