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NCT05891236 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
A Phase 1 study of Malaria, sponsored by Gates Medical Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT05891236 is a Phase 1 study of Malaria that has completed, run by Gates Medical Research Institute. The registered enrollment target is 61 participants, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05891236, a Phase 1 study of Malaria, has completed, sponsored by Gates Medical Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (76% lower). The listed sponsor is Gates Medical Research Institute, which has 6 total studies on file at ClinicalTrials.gov.
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.
NCT05891236 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
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.
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).
Who is sponsoring clinical trial NCT05891236?
This trial is sponsored by Gates Medical Research Institute, which has 6 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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