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NCT05891236
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
Phase 1 trial testing MAM01 1.5 mg/kg in Malaria in 61 participants. Completed in 13 December 2024.
13 December 2024
Quick facts
| Lead sponsor | Gates Medical Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 61 |
| Start date | 14 August 2023 |
| Primary completion | 13 December 2024 |
| Estimated completion | 13 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MAM01 1.5 mg/kg — full drug profile →
- Placebo
- MAM01 5 mg/kg — full drug profile →
- MAM01 10 mg/kg — full drug profile →
- MAM01 40 mg/kg
- MAM01 450 mg — full drug profile →
- Placebo
- MAM01 5 mg/kg — full drug profile →
- Control
- MAM01 600 mg — full drug profile →
- MAM01 900 mg
Conditions studied
- Malaria — all drugs for Malaria →
Sponsor
Gates Medical Research Institute
Who can join
Adults 18 to 50, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
A candidate antibody drug for prevention of malaria.
Williams KL, Guerrero S, Flores-Garcia Y, Kim D, et al · · 2024 · cited 41× · PMID 38167935 · DOI 10.1038/s41591-023-02659-z -
Vaccines and monoclonal antibodies: new tools for malaria control.
Miura K, Flores-Garcia Y, Long CA, Zavala F. · · 2024 · cited 24× · PMID 38656211 · DOI 10.1128/cmr.00071-23 -
Chemoprevention of malaria with long-acting oral and injectable drugs: an updated target product profile.
El Gaaloul M, Tchouatieu AM, Kayentao K, Campo B, et al · · 2024 · cited 11× · PMID 39425110 · DOI 10.1186/s12936-024-05128-1 -
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.
Lyke KE, Berry AA, Laurens MB, Winkler J, et al · · 2026 · cited 1× · PMID 41005346 · DOI 10.1016/s1473-3099(25)00481-5 -
Advances in population-based interventions to control falciparum malaria.
Glossop SE, Peto TJ, Adhikari B. · · 2025 · PMID 40973129 · DOI 10.1093/trstmh/traf088
Verify or expand the search:
- PubMed search for NCT05891236
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Gates Medical Research Institute trials
Trials by the same sponsor.
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- NCT07094932 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD09 · Phase 1 · completed
- NCT06707142 — A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11 · Phase 1 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05891236 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gates Medical Research Institute
- Last refreshed: 19 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05891236.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing