Healthy VolunteersPhase 1NCT06408857
Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population
A Phase 1 study testing MAM01 300 mg SC, MAM01 300 mg IM and MAM01 2000 mg IV in people with Healthy Volunteers, run by Gates Medical Research Institute at 2 sites in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MAM01 300 mg SC, MAM01 300 mg IM and MAM01 2000 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesUganda
- Study dates
- 28 Mar 2025to 28 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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 cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
JCRC-Joint Clinical Research Centre
Kampala, 10005
IDRC-Infectious Disease Research Collaboration, IDRC Tororo Hospital Station Road
Tororo, 749
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy Volunteers
- Being tested
- MAM01 300 mg SC, MAM01 300 mg IM, MAM01 2000 mg IV, MAM01 190 mg SC, MAM01 225 mg SC
- Keywords
- Malaria, Plasmodium falciparum, MAM01, De-Escalation, Dose Escalation, Perennial Malaria Transmission, Antibody, Monoclonal, Prevention, Pediatric, mAb-1797
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAM01 300 mg SCDrug
MAM01 300 mg will be administered SC
MAM01 300 mg IMDrug
MAM01 300 mg will be administered IM route
MAM01 2000 mg IVDrug
MAM01 2000 mg will be administered IV
MAM01 190 mg SCDrug
MAM01 190 mg will be administered SC
MAM01 225 mg SCDrug
MAM01 225 mg will be administered SC
MAM01 150 mg SCDrug
MAM01 150 mg will be administered SC
MAM01 150 mg IMDrug
MAM01 150 mg will be administered IM
MAM01 150 mg IVDrug
MAM01 150 mg will be administered IV
Placebo SCDrug
Placebo will be administered SC
Placebo IVDrug
Placebo will be administered IV.
Placebo IMDrug
Placebo will be administered IM
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1a (Healthy Adults): 300 milligrams (mg) MAM01 subcutaneously (SC) | Experimental | Participants will receive MAM01. Receives: Drug: MAM01 300 mg SC |
| Part A: Cohort 1b (Healthy Adults): 300 mg MAM01 intramuscularly (IM) | Experimental | Participants will receive MAM01. Receives: Drug: MAM01 300 mg IM |
| Part A: Cohort 1c (Healthy Adults): 2000 mg MAM01 intravenously (IV) | Experimental | Participants will receive MAM01. Receives: Drug: MAM01 2000 mg IV |
| Part B: Cohort 2a (Healthy Younger Children): 190 mg MAM01 or placebo SC | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 190 mg SC; Drug: Placebo SC |
| Part B: Cohort 2b (Healthy Younger Children): 225 mg MAM01 or placebo SC | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 225 mg SC; Drug: Placebo SC |
| Part B: Cohort 3a (Healthy Infants): 150 mg MAM01 or placebo SC | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 150 mg SC; Drug: Placebo SC |
| Part B: Cohort 3b (Healthy Infants): 150 mg MAM01 or placebo IM | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 150 mg IM; Drug: Placebo IM |
| Part B: Cohort 3c (Healthy Infants): 150 mg MAM01 or placebo IV | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 150 mg IV; Drug: Placebo IV |
| Part B: Cohort 4a (Healthy Infants): 150 mg MAM01 or placebo SC | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 150 mg SC; Drug: Placebo SC |
| Part B: Cohort 4b (Healthy Infants): 150 mg MAM01 or placebo IM | Experimental | Participants will be randomized in 3:1 ratio (MAM01 : PBO) Receives: Drug: MAM01 150 mg IM; Drug: Placebo IM |
| Part B: Cohort 4c (Healthy Infants): 150 mg MAM01 or placebo IV | Experimental | Participants will be randomized in 3:1 ratio (MAM01: PBO) Receives: Drug: MAM01 150 mg IV; Drug: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting Treatment-emergent adverse events (TEAEs)
Measured: 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
Measured: Up to 182 days post dose
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to IM dosing)
Measured: Up to 7 days post dose
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to SC dosing)
Measured: Up to 7 days post dose
Secondary outcomes (5)
Percentage of participants with graded abnormal clinical hematology and chemistry laboratory results
Measured: Up to 28 days post dose
Maximal observed blood concentration of MAM01 following the first dose (Cmax1)
Capillary blood samples will be collected for the analysis pharmacokinetic parameters. Blood concentrations of MAM01 will be measured using a validated immunoassay.
Measured: 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)
Measured: At Day 182 post first dose
Total Area Under the Concentration Curve (AUC) Day 0 - Day 182
Measured: From 0 to 182 days post dose
Percentage of participants with antidrug antibodies (ADAs) to MAM01
Measured: At Days 1, 28, 84, and 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start28 Mar 2025
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408857
- Sponsor's protocol ID
- Gates MRI-MAM01-103
- Status last verified
- Jun 2026
- First submitted
- 7 May 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD data that underlie the results presented herein
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06408857
- Acronym / sponsor ID
- Gates MRI-MAM01-103
- Conditions
- Healthy Volunteers
- Keywords
- Malaria, Plasmodium falciparum, MAM01, De-Escalation, Dose Escalation, Perennial Malaria Transmission, Antibody, Monoclonal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1a (Healthy Adults): 300 milligrams (mg) MAM01 subcutaneously (SC) | Experimental | Drug: MAM01 300 mg SCParticipants will receive MAM01. |
| Part A: Cohort 1b (Healthy Adults): 300 mg MAM01 intramuscularly (IM) | Experimental | Drug: MAM01 300 mg IMParticipants will receive MAM01. |
| Part A: Cohort 1c (Healthy Adults): 2000 mg MAM01 intravenously (IV) | Experimental | Drug: MAM01 2000 mg IVParticipants will receive MAM01. |
| Part B: Cohort 2a (Healthy Younger Children): 190 mg MAM01 or placebo SC | Experimental | Drug: MAM01 190 mg SC, Drug: Placebo SCParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 2b (Healthy Younger Children): 225 mg MAM01 or placebo SC | Experimental | Drug: MAM01 225 mg SC, Drug: Placebo SCParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 3a (Healthy Infants): 150 mg MAM01 or placebo SC | Experimental | Drug: MAM01 150 mg SC, Drug: Placebo SCParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 3b (Healthy Infants): 150 mg MAM01 or placebo IM | Experimental | Drug: MAM01 150 mg IM, Drug: Placebo IMParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 3c (Healthy Infants): 150 mg MAM01 or placebo IV | Experimental | Drug: MAM01 150 mg IV, Drug: Placebo IVParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 4a (Healthy Infants): 150 mg MAM01 or placebo SC | Experimental | Drug: MAM01 150 mg SC, Drug: Placebo SCParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 4b (Healthy Infants): 150 mg MAM01 or placebo IM | Experimental | Drug: MAM01 150 mg IM, Drug: Placebo IMParticipants will be randomized in 3:1 ratio (MAM01 : PBO) |
| Part B: Cohort 4c (Healthy Infants): 150 mg MAM01 or placebo IV | Experimental | Drug: MAM01 150 mg IV, Drug: Placebo IVParticipants will be randomized in 3:1 ratio (MAM01: PBO) |
Who may qualify
- Ages
- 3 months to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- PART A \& PART B
- Within 48 hours prior to randomization, acute febrile illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAM01 300 mg SCMAM01 300 mg will be administered SC | Drug | Part A: Cohort 1a (Healthy Adults): 300 milligrams (mg) MAM01 subcutaneously (SC) |
| MAM01 300 mg IMMAM01 300 mg will be administered IM route | Drug | Part A: Cohort 1b (Healthy Adults): 300 mg MAM01 intramuscularly (IM) |
| MAM01 2000 mg IVMAM01 2000 mg will be administered IV | Drug | Part A: Cohort 1c (Healthy Adults): 2000 mg MAM01 intravenously (IV) |
| MAM01 190 mg SCMAM01 190 mg will be administered SC | Drug | Part B: Cohort 2a (Healthy Younger Children): 190 mg MAM01 or placebo SC |
| MAM01 225 mg SCMAM01 225 mg will be administered SC | Drug | Part B: Cohort 2b (Healthy Younger Children): 225 mg MAM01 or placebo SC |
| MAM01 150 mg SCMAM01 150 mg will be administered SC | Drug | Part B: Cohort 3a (Healthy Infants): 150 mg MAM01 or placebo SC, Part B: Cohort 4a (Healthy Infants): 150 mg MAM01 or placebo SC |
| MAM01 150 mg IMMAM01 150 mg will be administered IM | Drug | Part B: Cohort 3b (Healthy Infants): 150 mg MAM01 or placebo IM, Part B: Cohort 4b (Healthy Infants): 150 mg MAM01 or placebo IM |
| MAM01 150 mg IVMAM01 150 mg will be administered IV | Drug | Part B: Cohort 3c (Healthy Infants): 150 mg MAM01 or placebo IV, Part B: Cohort 4c (Healthy Infants): 150 mg MAM01 or placebo IV |
| Placebo SCPlacebo will be administered SC | Drug | Part B: Cohort 2a (Healthy Younger Children): 190 mg MAM01 or placebo SC, Part B: Cohort 2b (Healthy Younger Children): 225 mg MAM01 or placebo SC, Part B: Cohort 3a (Healthy Infants): 150 mg MAM01 or placebo SC, Part B: Cohort 4a (Healthy Infants): 150 mg MAM01 or placebo SC |
| Placebo IVPlacebo will be administered IV. | Drug | Part B: Cohort 3c (Healthy Infants): 150 mg MAM01 or placebo IV, Part B: Cohort 4c (Healthy Infants): 150 mg MAM01 or placebo IV |
| Placebo IMPlacebo will be administered IM | Drug | Part B: Cohort 3b (Healthy Infants): 150 mg MAM01 or placebo IM, Part B: Cohort 4b (Healthy Infants): 150 mg MAM01 or placebo IM |
Primary outcome
Number of participants reporting Treatment-emergent adverse events (TEAEs)
Time frame: 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
Number of participants reporting solicited systemic AEs and solicited injection site AEs (applicable to IM dosing)
Time frame: 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
5 secondary outcomes
Percentage of participants with graded abnormal clinical hematology and chemistry laboratory results
Time frame: 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
Concentration at Day 182 (C182)
Time frame: 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
Percentage of participants with antidrug antibodies (ADAs) to MAM01
Time frame: At Days 1, 28, 84, and 182
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD data that underlie the results presented herein
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAM01 300 mg SC, MAM01 300 mg IM and MAM01 2000 mg IV in people with Healthy Volunteers, run by Gates Medical Research Institute at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting Treatment-emergent adverse events (TEAEs) (time frame: Up to 28 days post dose (Part A and B)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.