Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New shot could shield against malaria for months

NCT ID NCT06408857

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Vår säkerhetsrekommendation!

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.