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Monoclonal Antibodies
MAM01 for Malaria
Phase 1
Recruiting
Research Sponsored by Bill & Melinda Gates Medical Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, day 0: end of infusion (eoi), 1, 3 and 6 hours, day 1: 24 hours, day 2: 48 hours, days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Awards & highlights
Study Summary
This trial tests a drug to help protect against malaria. It evaluates safety, side effects, how it acts in the body, & its effectiveness.
Who is the study for?
Healthy adults who can become pregnant must use effective contraception and have a negative pregnancy test. Participants need to be healthy, with a BMI of 18-30 kg/m^2 up to 220 pounds, not in other trials recently, no significant medical conditions or immune system issues, and must have completed their primary COVID vaccine series.Check my eligibility
What is being tested?
The trial is testing MAM01, an antibody against malaria. It's the first time humans are trying it. The study will compare MAM01 with a placebo to see how safe it is and how the body processes it. Some people will get repeat doses under the skin.See study design
What are the potential side effects?
Since this is a First-in-Human trial for MAM01, specific side effects aren't known yet but could include typical drug reactions like injection site pain, fever, fatigue or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose, day 0: end of infusion (eoi), 1, 3 and 6 hours, day 1: 24 hours, day 2: 48 hours, days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, day 0: end of infusion (eoi), 1, 3 and 6 hours, day 1: 24 hours, day 2: 48 hours, days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants reporting serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs) and adverse events special interest (AESIs)
Number of participants reporting solicited local and systemic adverse events (AEs) in the SC cohorts
Number of participants reporting unsolicited AEs (single dose or multiple dose)
+2 moreSecondary outcome measures
AUC from Time=0 extrapolated to infinity (AUC0-infinity) of MAM01
Area under the curve (AUC) from Time=0 to the last measurable concentration (AUC0-t) of MAM01
Bioavailability of SC formulation following single and repeat dosing of MAM01
+14 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Part B: Dose Expansion Cohort 6: Group 3: MAM01 and placebo SC (optional)Experimental Treatment2 Interventions
8 participants will receive a single SC dose of either MAM01 or placebo. The dose will be selected by applying a PK-PD model from the Part A data to estimate a (data-driven) protection threshold.
Group II: Part B: Dose Expansion Cohort 6: Group 2: MAM01 and placebo SC (optional)Experimental Treatment2 Interventions
8 participants will receive a single SC dose of either MAM01 or placebo. The dose will be selected by applying a PK-PD model from the Part A data to estimate a (data-driven) protection threshold.
Group III: Part B: Dose Expansion Cohort 6: Group 1: MAM01 and placebo SC (optional)Experimental Treatment2 Interventions
8 participants will receive a single SC dose of either MAM01 or placebo. The dose will be selected by applying a PK-pharmacodynamic (PD) model from the Part A data to estimate a (data-driven) protection threshold.
Group IV: Part A: Single Ascending Dose (SAD): Dose escalation cohort 1: MAM01 and placebo Intravenous (IV)Experimental Treatment3 Interventions
2 sentinel participants will be randomized in a 1:1 ratio to receive MAM01 1.5 milligrams per kilogram (mg/kg) IV or placebo. Following at least a 24-hour safety review period, the 6 remaining participants of Cohort 1 will be randomized in a 5:1 ratio to receive MAM01 1.5 mg/kg IV or placebo.
Group V: Part A: SAD dosing: Dose escalation Cohort 5: MAM01 and placebo IVExperimental Treatment3 Interventions
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 40 mg/kg IV or placebo
Group VI: Part A: SAD dosing: Dose escalation Cohort 4: MAM01 and placebo IVExperimental Treatment3 Interventions
8 participants will be randomly assigned in a 6:2 ratio to receive MAM01 10 mg/kg IV or placebo.
Group VII: Part A: SAD dosing: Dose escalation Cohort 3: MAM01 and placebo IVExperimental Treatment3 Interventions
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 5 mg/kg IV or placebo.
Group VIII: Part A: SAD dosing: Dose escalation Cohort 2: MAM01 and placebo SCExperimental Treatment3 Interventions
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 5 mg/kg SC or placebo
Group IX: Part A: Multiple Ascending Dose (MAD) (Repeat dosing): MAM01 and placebo SCExperimental Treatment3 Interventions
Participants from Cohort 2 and from Cohort 3 will receive 5 mg/kg MAM01 SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Bill & Melinda Gates Medical Research InstituteLead Sponsor
12 Previous Clinical Trials
32,138 Total Patients Enrolled
+1 866 789 5767Study DirectorBill & Melinda Gates Medical Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a fever of 99.5°F or higher on the day of treatment.I have a serious health condition that my doctor is concerned about.I am not pregnant or breastfeeding.I have an autoimmune disease, immune deficiency, or am on immunosuppressive therapy.I am a woman capable of becoming pregnant and agree to use birth control from 28 days before joining the study until 10 months after the last treatment.I can sign the consent form and follow the trial's rules.I have completed the primary series of COVID vaccinations.I am not taking medications that react badly with chloroquine or Malarone.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Dose Expansion Cohort 6: Group 2: MAM01 and placebo SC (optional)
- Group 2: Part B: Dose Expansion Cohort 6: Group 1: MAM01 and placebo SC (optional)
- Group 3: Part B: Dose Expansion Cohort 6: Group 3: MAM01 and placebo SC (optional)
- Group 4: Part A: SAD dosing: Dose escalation Cohort 5: MAM01 and placebo IV
- Group 5: Part A: SAD dosing: Dose escalation Cohort 2: MAM01 and placebo SC
- Group 6: Part A: Multiple Ascending Dose (MAD) (Repeat dosing): MAM01 and placebo SC
- Group 7: Part A: Single Ascending Dose (SAD): Dose escalation cohort 1: MAM01 and placebo Intravenous (IV)
- Group 8: Part A: SAD dosing: Dose escalation Cohort 3: MAM01 and placebo IV
- Group 9: Part A: SAD dosing: Dose escalation Cohort 4: MAM01 and placebo IV
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this medical study restricted to those under 35 or can people above that age participate?
"The age range for participation in this medical trial is 18-50 years old."
Answered by AI
What are the prerequisites for participating in this research project?
"To qualify, prospective participants must fulfill the criteria of having malaria and being between 18-50 years old. The total number of clinical trial candidates is 61."
Answered by AI
To what extent could this therapy be detrimental to patients?
"This experimental intervention is deemed relatively risky, as it only has preliminary evidence of safety and efficacy; thusly receiving a score of 1."
Answered by AI
Is there any availability for individuals to participate in this clinical research?
"As per the information on clinicaltrials.gov, recruitment for this medical research has since closed; it was initially posted on July 1st 2023 and had its last update on May 26th 2023. Nonetheless, there are still 94 other trials actively recruiting participants at present."
Answered by AI
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