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This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). This study will evaluate the safety, tolerability, pharmacokinetics (PK), and protective efficacy of MAM01, as well as safety and PK of repeat subcutaneous (SC) dosing. Part A will have a double-blind, placebo-controlled design. Part B will randomize participants to one of three open-label MAM01 dose groups; a separate non-randomized group will be enrolled to include participants who will receive no treatment and act as infectivity controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Ascending Dose (SAD): Dose escalation cohort 1: MAM01 and placebo Intravenous (IV) | Experimental | 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. |
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| Part A: SAD dosing: Dose escalation Cohort 2: MAM01 and placebo SC | Experimental | 7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 5 mg/kg SC or placebo |
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| Part A: SAD dosing: Dose escalation Cohort 3: MAM01 and placebo IV | Experimental | 7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 5 mg/kg IV or placebo. |
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| Part A: SAD dosing: Dose escalation Cohort 4: MAM01 and placebo IV | Experimental | 8 participants will be randomly assigned in a 6:2 ratio to receive MAM01 10 mg/kg IV or placebo. |
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| Part A: SAD dosing: Dose escalation Cohort 5: MAM01 and placebo IV |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAM01 1.5 mg/kg | Biological | 1.5 mg/kg MAM01 will be administered via IV route. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Adverse Events (AEs) in the Subcutaneous Cohorts | Solicited AEs were defined events participants were specifically asked about, which were recorded by participants in the memory aid card. Solicited AES included local injection site AEs (pain, redness, swelling, itching and bruising) and systemic AEs (fever, chills, headache, fatigue, nausea, muscle pain and joint pain). A Solicited AE does not necessarily have a causal relationship with the intervention. | Day 1 to Day 7 post dose |
| Number of Participants Reporting Unsolicited Adverse Events | In this study an unsolicited AE is any AE not captured as a solicited AE in the Memory Aid Card between Day 0 and Day 7 after MAM01 dosing, and all AEs occurring after Day 7 post dose were collected as Unsolicited AEs. | Through Day 28 post dose |
| Number of Participants Reporting Serious Adverse Events (SAEs) Including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events Special Interest (AESIs) | A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting. | Up to Day 168 |
| Number of Participants Who Received 2 Doses Reporting SUSARs, SAEs and AESIs | A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Observed Concentration (Cmax) Following Single Dose of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
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Inclusion criteria:
Participants who are healthy as determined by medical evaluation including medical history, physical examination and laboratory tests
Body Mass Index (BMI) 18 to 30 kilograms per square meter (kg/m^2) (inclusive) to a maximum of 220 pounds
Both males and females are eligible to participate as per the following:
a. Female participants physically capable of pregnancy, have at least one negative pregnancy test during Screening, on the day of enrollment, prior to Investigational product (IP) administration, prior to CHM and at the start of antimalarial treatment, and who agree to use effective contraception to avoid pregnancy from 28 days before enrollment through 10 months after last administration of investigational product are eligible to participate.
Capable of giving signed Informed Consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and the trial protocol, and completion of a test of understanding if he/she may participate in the CHMI procedure
Reported completion of primary Coronavirus Disease (COVID) vaccine series is documented
Exclusion criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| +1 866 789 5767 | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Vaccine Development and Global Health, 685 W. Baltimore Street | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41005346 | Derived | Lyke KE, Berry AA, Laurens MB, Winkler J, Joshi S, Koudjra AR, Butler L, Billingsley PF, Pascini T, Patil A, Sim BKL, Fitzgerald G, Riegel J, Andrews K, Levi M, Anderson AB, Wells CD, Liu H, Huleatt J, Miller RS. Human monoclonal antibody MAM01 for protection against malaria in adults in the USA: a first-in-human, phase 1, dose-escalation, double-blind, placebo-controlled, adaptive trial. Lancet Infect Dis. 2026 Feb;26(2):170-181. doi: 10.1016/S1473-3099(25)00481-5. Epub 2025 Sep 23. |
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In Part A, 37 of 38 participants were randomized to MAM01 or placebo, with 1 participant serving as an untreated infectivity control. Ten randomized participants did not undergo CHMI due to rescheduling secondary to a failure to generate infectious mosquitoes. In Part B, 25 participants were enrolled; 18 were dosed, 1 participant was randomized but withdrew prior to dosing, and 6 participants served as infectivity controls. One participant did not undergo CHMI due to concurrent illness.
A two-part randomized, dose-escalation study to assess anti-malarial human monoclonal antibody MAM01 in healthy, malaria-naïve adults. Part A: double-blind, placebo-controlled, single-ascending dose (SAD) study, while Part B: dose expansion was open-label. The study evaluated safety, tolerability, pharmacokinetics, and protective efficacy of MAM01 against controlled human malaria infection (CHMI) with Plasmodium falciparum NF54. Safety and PK of repeat subcutaneous dosing were also evaluated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg. |
| FG001 | Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2024 | Dec 17, 2025 |
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| Experimental |
7 participants will be randomly assigned in a 6:1 ratio to receive MAM01 40 mg/kg IV or placebo |
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| Part A: Multiple Ascending Dose (MAD) (Repeat dosing): MAM01 | Experimental | Participants from Cohort 2 and from Cohort 3 will receive 5 mg/kg MAM01 SC. |
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| Part B: Dose Expansion Cohort 6: Group 1: MAM01 | Experimental | 6 participants will receive a 450 mg SC dose of MAM01. The dose was selected by applying a PK-pharmacodynamic (PD) model from the Part A data to estimate a (data-driven) protection threshold at Controlled Human Malaria Infection (CHMI). |
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| Part B: Dose Expansion Cohort 6: Group 2: MAM01 | Experimental | 8 participants will receive a 600 mg SC dose of MAM01. The dose was selected by applying a PK-PD model from the Part A data to estimate a (data-driven) protection threshold at CHMI |
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| Part B: Dose Expansion Cohort 6: Group 3: MAM01 | Experimental | 8 participants will receive 900 mg SC dose of MAM01. The dose was selected by applying a PK-PD model from the Part A data to estimate a (data-driven) protection threshold at CHMI. |
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| Internal Infectivity Controls | Experimental | 6 participants will be enrolled into a non-randomized group prior to CHMI. These participants will receive no treatment and act as infectivity controls |
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| Placebo | Biological | Placebo will be administered via IV route. |
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| MAM01 5 mg/kg | Biological | 5 mg/kg MAM01 will be administered via SC route. |
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| MAM01 10 mg/kg | Biological | 10 mg/kg MAM01 will be administered via IV route. |
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| MAM01 40 mg/kg | Biological | 40 mg/kg MAM01 will be administered via IV route. |
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| MAM01 450 mg | Biological | MAM01 will be administered via SC route. |
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| Placebo | Biological | Placebo will be administered via SC route. |
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| MAM01 5 mg/kg | Biological | 5 mg/kg MAM01 will be administered via IV route. |
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| Control | Other | No drug or placebo will be administered. |
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| MAM01 600 mg | Biological | MAM01 will be administered via SC route. |
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| MAM01 900 mg | Biological | MAM01 will be administered via SC route. |
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| Through Day 336 |
| Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters | Blood samples were collected for the assessment of alanine transaminase, aspartate aminotransferase, alkaline phosphatase, total carbon-dioxide (CO2), chloride, total bilirubin, creatinine, blood urea nitrogen, glucose, albumin, total protein, sodium and potassium. | Through Day 336 |
| Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, platelet count, and white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, and monocytes. | Through Day 336 |
| Cmax Following Repeat Dosing of MAM01 |
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. |
| 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 |
| Area Under the Curve (AUC) From Time=0 to the Last Measurable Concentration (AUC0-t) Following Single Dose of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| AUC (0-t) Following Repeat Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| Partial AUC's Time= 0 to the CHMI Challenge (AUC0-CHMI) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| Concentration at the Time of CHMI (CCHMI) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| Blood Terminal Elimination Rate Constant (λz) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| Terminal Half Life (t1/2) Following Single Dose of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Time Frame: 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 |
| t1/2 Following Repeat Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| AUC From Time=0 Extrapolated to Infinity (AUC0-infinity) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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 |
| Absolute Bioavailability of SC Formulation Following Repeated Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | 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, 280 and 378 post-dose |
| Accumulation Ratio (AUC0-168) Following Repeated Doses of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. The accumulation ratio was calculated as the ratio of AUC (0-168) (post first dose) to AUC (210-378) (post redose). | 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 and 168 post-dose |
| Number of Participants With Confirmed Pf Infection Assessed by Quantitative Polymerase Chain Reaction Assay (qRT-PCR) After CHMI | The characterization of protective efficacy against Pf following CHMI challenge, was assessed by evaluating the presence or absence of Pf infection as determined by qRT-PCR after CHMI (planned through 4 weeks post-CHMI) and evaluating the time to parasitemia after CHMI in each cohort. | Up to Day 27 post-CHMI |
| Time to Parasitemia After CHMI | Parasitemia was assessed by qRT-PCR up to Day 27 following CHMI. In addition, a thick blood smear was prepared for microscopic analysis, which was examined only once the first qRT-PCR sample tested positive. Daily parasitemia monitoring continued until the participant had a confirmed initial positive qRT-PCR. The first positive qRT-PCR triggered either a second PCR test or microscopic analysis of the blood smear. Once two positive results were obtained, rescue therapy was initiated. | Up to Day 27 post-CHMI |
| Cohorts 1, 4 and 5: Numbers of Participants With Seroconversion | The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints. | Up to Day 280 |
| Cohorts 2 and 3: Numbers of Participants Receiving 2 Doses With Seroconversion | The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints. | Up to Day 378 |
| Cohort 6: Numbers of Participants With Seroconversion | The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints. | Up to Day 84 |
Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, regardless of the initial randomized treatment allocation.
| FG002 | Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC) | Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, regardless of the initial randomized treatment allocation. |
| FG003 | Part A (SAD Cohort 4): MAM01 10 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| FG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| FG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). One randomized Cohort 2 placebo participant received MAM01 SC following CHMI as the second dose, per protocol. |
| FG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| FG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| FG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| FG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| FG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
| Received SC Dose |
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| COMPLETED | The participant flow has been presented for "Enrolled Population" who signed the informed consent form. One participant in Cohort 6 Group 2: MAM01 600 mg/kg discontinued from the trial (withdrew consent) prior to dosing and was replaced. |
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| NOT COMPLETED |
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Safety Population comprised of all participants who were randomly assigned to a trial intervention and received the intervention, and the untreated infectivity control participants. One participant in Cohort 6 Group 2: MAM01 600 mg/kg discontinued from the trial (withdrew consent) prior to dosing.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg. |
| BG001 | Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC) | Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation. |
| BG002 | Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC) | Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation. |
| BG003 | Part A (SAD Cohort 4): MAM01 10 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| BG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| BG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| BG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| BG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| BG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| BG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| BG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
| BG011 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Solicited Adverse Events (AEs) in the Subcutaneous Cohorts | Solicited AEs were defined events participants were specifically asked about, which were recorded by participants in the memory aid card. Solicited AES included local injection site AEs (pain, redness, swelling, itching and bruising) and systemic AEs (fever, chills, headache, fatigue, nausea, muscle pain and joint pain). A Solicited AE does not necessarily have a causal relationship with the intervention. | Safety Population receiving MAM01 SC dose. | Posted | Count of Participants | Participants | Day 1 to Day 7 post dose |
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| Primary | Number of Participants Reporting Unsolicited Adverse Events | In this study an unsolicited AE is any AE not captured as a solicited AE in the Memory Aid Card between Day 0 and Day 7 after MAM01 dosing, and all AEs occurring after Day 7 post dose were collected as Unsolicited AEs. | Safety Population. | Posted | Count of Participants | Participants | Through Day 28 post dose |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) Including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events Special Interest (AESIs) | A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 168 |
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| Primary | Number of Participants Who Received 2 Doses Reporting SUSARs, SAEs and AESIs | A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting. | Safety Population. | Posted | Count of Participants | Participants | Through Day 336 |
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| Primary | Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters | Blood samples were collected for the assessment of alanine transaminase, aspartate aminotransferase, alkaline phosphatase, total carbon-dioxide (CO2), chloride, total bilirubin, creatinine, blood urea nitrogen, glucose, albumin, total protein, sodium and potassium. | Safety Population. | Posted | Count of Participants | Participants | Through Day 336 |
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| Primary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, platelet count, and white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, and monocytes. | Safety Population. | Posted | Count of Participants | Participants | Through Day 336 |
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| Secondary | Maximal Observed Concentration (Cmax) Following Single Dose of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population comprised of all participants who were randomly assigned to trial intervention, received the trial intervention, and have baseline and on-study concentration-time data available. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | 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 |
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| Secondary | Cmax Following Repeat Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | 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 |
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| Secondary | Area Under the Curve (AUC) From Time=0 to the Last Measurable Concentration (AUC0-t) Following Single Dose of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*micrograms per milliliter | 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 |
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| Secondary | AUC (0-t) Following Repeat Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*micrograms per milliliter | 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 |
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| Secondary | Partial AUC's Time= 0 to the CHMI Challenge (AUC0-CHMI) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. Only those participants with data available at specified timepoints has been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*micrograms per milliliter | 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 |
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| Secondary | Concentration at the Time of CHMI (CCHMI) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. Only participants with data available at the specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | 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 |
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| Secondary | Blood Terminal Elimination Rate Constant (λz) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/day | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Half Life (t1/2) Following Single Dose of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. Only participants with data available at the specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | Time Frame: 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 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | t1/2 Following Repeat Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. Only those participants with data available at specified timepoints has been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC From Time=0 Extrapolated to Infinity (AUC0-infinity) of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | day*micrograms per milliliter | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Bioavailability of SC Formulation Following Repeated Dosing of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Unitless | 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, 280 and 378 post-dose |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Ratio (AUC0-168) Following Repeated Doses of MAM01 | Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. The accumulation ratio was calculated as the ratio of AUC (0-168) (post first dose) to AUC (210-378) (post redose). | Pharmacokinetic Population. Only participants with data available at the specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 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 and 168 post-dose |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Confirmed Pf Infection Assessed by Quantitative Polymerase Chain Reaction Assay (qRT-PCR) After CHMI | The characterization of protective efficacy against Pf following CHMI challenge, was assessed by evaluating the presence or absence of Pf infection as determined by qRT-PCR after CHMI (planned through 4 weeks post-CHMI) and evaluating the time to parasitemia after CHMI in each cohort. | Efficacy Population. Only participants with data available at the specified timepoints have been presented. | Posted | Count of Participants | Participants | Up to Day 27 post-CHMI |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Parasitemia After CHMI | Parasitemia was assessed by qRT-PCR up to Day 27 following CHMI. In addition, a thick blood smear was prepared for microscopic analysis, which was examined only once the first qRT-PCR sample tested positive. Daily parasitemia monitoring continued until the participant had a confirmed initial positive qRT-PCR. The first positive qRT-PCR triggered either a second PCR test or microscopic analysis of the blood smear. Once two positive results were obtained, rescue therapy was initiated. | Efficacy Population. Only participants with data available at the specified timepoints have been presented. | Posted | Median | 95% Confidence Interval | Days | Up to Day 27 post-CHMI |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohorts 1, 4 and 5: Numbers of Participants With Seroconversion | The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints. | Immunogenicity Population comprised of all participants who were randomly assigned to trial intervention, received the trial intervention, and have at least one valid ADA result | Posted | Count of Participants | Participants | Up to Day 280 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohorts 2 and 3: Numbers of Participants Receiving 2 Doses With Seroconversion | The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints. | Immunogenicity Population. | Posted | Count of Participants | Participants | Up to Day 378 |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohort 6: Numbers of Participants With Seroconversion | The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints. | Immunogenicity Population. | Posted | Count of Participants | Participants | Up to Day 84 |
|
|
Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC) | Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, 30 weeks after receiving the first dose, regardless of the initial randomized treatment allocation. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC) | Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, 30 weeks after receiving the first dose, regardless of the initial randomized treatment allocation. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Part A (SAD Cohort 4): MAM01 10 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. | 0 | 6 | 0 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression suicidal | Psychiatric disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site redness | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site itching | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Muscle pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Puncture site bruise | General disorders | MedDRA (26.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Gates MRI | 18577022108 | clinical.trials@gatesmri.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2024 | Dec 17, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Any general body symptom |
|
| Part A (SAD Cohort 4): MAM01 10 mg/kg IV |
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single dose of MAM01 40 mg/kg. |
| OG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| OG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| OG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| OG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
|
|
| Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC) |
Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation. |
| OG003 | Part A (SAD Cohort 4): MAM01 10 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| OG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| OG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| OG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG003 |
| Part A (SAD Cohort 4): MAM01 10 mg/kg IV |
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| OG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| OG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| OG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
|
|
| OG003 |
| Part A (SAD Cohort 4): MAM01 10 mg/kg IV |
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| OG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| OG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| OG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
|
|
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
|
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
|
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
|
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG006 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG007 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
|
|
|
|
| OG003 | Part A (SAD Cohort 4): MAM01 10 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| OG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| OG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| OG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
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Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
| OG003 | Part A (SAD Cohort 4): MAM01 10 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 10 mg/kg. |
| OG004 | Part A (SAD Cohort 5): MAM01 40 mg/kg IV | Participants were randomized to receive a single IV dose of MAM01 40 mg/kg. |
| OG005 | Part A: Placebo | Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI. |
| OG006 | Part A: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls. |
| OG007 | Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 450 mg/kg. |
| OG008 | Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 600 mg/kg. |
| OG009 | Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC | Participants were randomized to receive single SC dose of MAM01 900 mg/kg. |
| OG010 | Part B: Infectivity Controls | Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls. |
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