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

June 1, 2026 updated by: Gates Medical Research Institute

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 and infants).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Uganda
      • Kampala, Uganda, 10005
        • JCRC-Joint Clinical Research Centre
      • Tororo, Uganda, 749
        • IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: Cohort 1a (Healthy Adults): 300 milligrams (mg) MAM01 subcutaneously (SC)
Participants will receive MAM01.
Drug: MAM01 300 mg SC
MAM01 300 mg will be administered SC
Experimental: Part A: Cohort 1b (Healthy Adults): 300 mg MAM01 intramuscularly (IM)
Participants will receive MAM01.
Drug: MAM01 300 mg IM
MAM01 300 mg will be administered IM route
Experimental: Part A: Cohort 1c (Healthy Adults): 2000 mg MAM01 intravenously (IV)
Participants will receive MAM01.
Drug: MAM01 2000 mg IV
MAM01 2000 mg will be administered IV
Experimental: Part B: Cohort 2a (Healthy Younger Children): 190 mg MAM01 or placebo SC
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: Placebo SC
Placebo will be administered SC
Drug: MAM01 190 mg SC
MAM01 190 mg will be administered SC
Experimental: Part B: Cohort 2b (Healthy Younger Children): 225 mg MAM01 or placebo SC
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: Placebo SC
Placebo will be administered SC
Drug: MAM01 225 mg SC
MAM01 225 mg will be administered SC
Experimental: Part B: Cohort 3a (Healthy Infants): 150 mg MAM01 or placebo SC
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: Placebo SC
Placebo will be administered SC
Drug: MAM01 150 mg SC
MAM01 150 mg will be administered SC
Experimental: Part B: Cohort 3b (Healthy Infants): 150 mg MAM01 or placebo IM
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: Placebo IM
Placebo will be administered IM
Drug: MAM01 150 mg IM
MAM01 150 mg will be administered IM
Experimental: Part B: Cohort 3c (Healthy Infants): 150 mg MAM01 or placebo IV
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: MAM01 150 mg IV
MAM01 150 mg will be administered IV
Drug: Placebo IV
Placebo will be administered IV.
Experimental: Part B: Cohort 4a (Healthy Infants): 150 mg MAM01 or placebo SC
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: Placebo SC
Placebo will be administered SC
Drug: MAM01 150 mg SC
MAM01 150 mg will be administered SC
Experimental: Part B: Cohort 4b (Healthy Infants): 150 mg MAM01 or placebo IM
Participants will be randomized in 3:1 ratio (MAM01 : PBO)
Drug: Placebo IM
Placebo will be administered IM
Drug: MAM01 150 mg IM
MAM01 150 mg will be administered IM
Experimental: Part B: Cohort 4c (Healthy Infants): 150 mg MAM01 or placebo IV
Participants will be randomized in 3:1 ratio (MAM01: PBO)
Drug: MAM01 150 mg IV
MAM01 150 mg will be administered IV
Drug: Placebo IV
Placebo will be administered IV.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to IM dosing)
Time Frame: Up to 7 days post dose
Up to 7 days post dose
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to SC dosing)
Time Frame: Up to 7 days post dose
Up to 7 days post dose
Number of participants reporting Treatment-emergent adverse events (TEAEs)
Time Frame: Up to 28 days post dose (Part A and B)
Up to 28 days post dose (Part A and B)
Number of participants reporting serious adverse events (SAEs), adverse events of special interest (AESI), and AEs leading to discontinuation
Time Frame: Up to 182 days post dose
Up to 182 days post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with graded abnormal clinical hematology and chemistry laboratory results
Time Frame: Up to 28 days post dose
Up to 28 days post dose
Maximal observed blood concentration of MAM01 following the first dose (Cmax1)
Time Frame: Pre- and post-dose (IV dosing groups only) at Day 1, 4, 7, 14, 28, 56, 84, 112, 140, and 182
Capillary blood samples will be collected for the analysis pharmacokinetic parameters. Blood concentrations of MAM01 will be measured using a validated immunoassay.
Pre- and post-dose (IV dosing groups only) at Day 1, 4, 7, 14, 28, 56, 84, 112, 140, and 182
Concentration at Day 182 (C182)
Time Frame: At Day 182 post first dose
At Day 182 post first dose
Total Area Under the Concentration Curve (AUC) Day 0 - Day 182
Time Frame: From 0 to 182 days post dose
From 0 to 182 days post dose
Percentage of participants with antidrug antibodies (ADAs) to MAM01
Time Frame: At Days 1, 28, 84, and 182
At Days 1, 28, 84, and 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gates Medical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gates MRI-MAM01-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD data that underlie the results presented herein

IPD Sharing Time Frame

Within 12 months of the study completion date

IPD Sharing Access Criteria

Anonymized participant-level data may be shared with external researchers in accordance with trial participants' written and executed informed consent and applicable local regulations. Qualified researchers may submit a request along with a research proposal to Gates MRI for review. A data sharing agreement must be in place before any clinical trial data are shared. Additional restrictions may apply due to contractual obligations or regulatory constraints.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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