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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population (NCT06408857) is a Phase 1 interventional studying Healthy Volunteers, sponsored by Gates Medical Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Healthy Volunteers, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 123 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Healthy Volunteers subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: PART A - Male or female adults aged 18 to 55 years inclusive at the time of signing the willing to sign a consent form form (ICF), who are capable of, and willing to provide, willing to sign a consent form - 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

MAM01 300 mg SC

MAM01 300 mg will be administered SC

DRUG

MAM01 300 mg IM

MAM01 300 mg will be administered IM route

DRUG

MAM01 2000 mg IV

MAM01 2000 mg will be administered IV

DRUG

MAM01 190 mg SC

MAM01 190 mg will be administered SC

DRUG

MAM01 225 mg SC

MAM01 225 mg will be administered SC

DRUG

MAM01 150 mg SC

MAM01 150 mg will be administered SC

DRUG

MAM01 150 mg IM

MAM01 150 mg will be administered IM

DRUG

MAM01 150 mg IV

MAM01 150 mg will be administered IV

DRUG

Placebo SC

Placebo will be administered SC

DRUG

Placebo IV

Placebo will be administered IV.

DRUG

Placebo IM

Placebo will be administered IM

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

JCRC-Joint Clinical Research Centre
Kampala, Uganda
IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road
Tororo, Uganda

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06408857), the sponsor (Gates Medical Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06408857 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06408857?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06408857?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06408857. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06408857. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.