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Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
NCT05891236 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL MAM01 1.5 mg/kg
- BIOLOGICAL MAM01 5 mg/kg
- BIOLOGICAL MAM01 10 mg/kg
- BIOLOGICAL MAM01 40 mg/kg
Study Locations (1)
Maryland
- Center for Vaccine Development and Global Health, 685 W. Baltimore Street — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2024-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05891236
The ClinicalTrials.gov registry entry for NCT05891236 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gates Medical Research Institute, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05891236 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05891236 about?
NCT05891236 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults". 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 ...
What is the current status of trial NCT05891236?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2023-08-14. Estimated completion is 2024-12-13.
What conditions does trial NCT05891236 study?
This clinical trial studies the following conditions: Malaria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05891236?
The interventions under investigation include: Placebo (BIOLOGICAL), MAM01 1.5 mg/kg (BIOLOGICAL), MAM01 5 mg/kg (BIOLOGICAL), MAM01 10 mg/kg (BIOLOGICAL), MAM01 40 mg/kg (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05891236?
This trial is sponsored by Gates Medical Research Institute, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05891236 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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