New shot could shield against malaria for months
NCT ID NCT06408857
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new drug called MAM01 to see if it is safe and could help prevent malaria for at least 4 months. It involved 125 healthy adults and children living in parts of Africa where malaria is common. Researchers gave different doses of MAM01 or a placebo and monitored for side effects and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MAM01
- What this could lead to
- If successful, MAM01 could provide a new way to prevent malaria for several months, reducing infections in areas where malaria is common.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if MAM01 will actually prevent malaria. The results may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
125 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
May 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 months to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road
Tororo, 749, Uganda
-
JCRC-Joint Clinical Research Centre
Kampala, 10005, Uganda
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe the nerve highways behind strength gains
- New syphilis test kits put to the test with donated blood
- Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people
- Novo nordisk tests Brand-New molecule in humans for the first time
- New sedative candidate goes Head-to-Head with propofol in early human test
- Can a Room-Temperature dairy drink build muscle?