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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: Completed Phase 1 study of Malaria, sponsored by Gates Medical Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT05891236 record still lists
NCT05891236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Malaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05891236's enrollment target sits among peer trials
61 17th of 27 higher than 11 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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