Evaluating a new malaria prevention drug in healthy volunteers in Africa
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 is testing a new malaria prevention drug called MAM01 in healthy adults and young children in Africa to see if it's safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | 3 Months to 55 Years |
| Sex | All |
| Sponsor | Bill & Melinda Gates Medical Research Institute Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Kampala and 1 other locations) |
| Trial ID | NCT06408857 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of a new drug called MAM01 aimed at preventing malaria in healthy individuals. It consists of two parts: Part A focuses on dose escalation in adults aged 18 to 55, while Part B involves age de-escalation and dose escalation in young children and infants. The trial will take place in regions of Africa where malaria is prevalent, and participants will be monitored for safety and drug effectiveness over a period of four months.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18 to 55 and children aged 12 months to 5 years living in malaria-endemic areas.
Not a fit: Patients with existing malaria infections or those outside the specified age ranges may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new preventive treatment for malaria, significantly reducing the incidence of the disease in vulnerable populations.
How similar studies have performed: Previous studies on malaria prevention have shown promise, but this specific approach with MAM01 is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 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 * Any contraindication for a subcutaneous injection, intravenous injection, or intramuscular injection, as applicable * For Part A female participants who are breastfeeding, pregnant, or unable or unwilling to adhere to required contraception * For Part B, in the opinion of the Investigator, the parent or LAR may not be able to ensure participant compliance with the requirements of the trial
Where this trial is running
Kampala and 1 other locations
- JCRC-Joint Clinical Research Centre — Kampala, Uganda (Recruiting)
- IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road — Tororo, Uganda (Recruiting)
Study contacts
- Study coordinator: Gates MRI
- Email: clinical.trials@gatesmri.org
- Phone: +1 866 789 5767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.