NCT02562872 is a Phase 1 clinical trial of DSM265 in Healthy, sponsored by Medicines for Malaria Venture.

Who is sponsoring NCT02562872?

NCT02562872 is sponsored by Medicines for Malaria Venture.

What drugs are being tested in NCT02562872?

Interventions in NCT02562872: DSM265, Placebo, Sporozoites, Infective mosquito bite.

Is NCT02562872 still recruiting?

NCT02562872 is currently completed. Last updated 13 January 2022.

Last reviewed 2022-01-13 · How we verify

NCT02562872

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Proof-of-concept, Single Center Study in Healthy Adult Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Prophylactic Activity of Single Dose DSM265 in a Controlled Human Malarial Infection Challenge Either by Direct Venous Inoculation of Plasmodium Falciparum Sporozoites or Mosquito-borne Plasmodium Falciparum

Completed Phase 1 Last updated 13 January 2022

What this trial tests

Phase 1 trial testing DSM265 in Healthy in 24 participants. Completed in 1 May 2017.

Timeline

1 March 2016

Primary endpoint
1 May 2017

1 May 2017

Quick facts

Lead sponsor	Medicines for Malaria Venture
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	24
Start date	1 March 2016
Primary completion	1 May 2017
Estimated completion	1 May 2017
Sites	1 location across United States

Drugs / interventions tested

DSM265 — full drug profile →
Placebo
Sporozoites — full drug profile →
Infective mosquito bite — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Medicines for Malaria Venture — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of subjects with positive parasitemia
Time frame: 28 days
positive parasitemia detected by qRT-PCR
Time interval between challenge and the first positive parasitemia
Time frame: 28 days
Time from infection to peripheral parasitemia (qRT-PCR) in DSM265 / placebo treated subjects in each cohort given as a geometric mean \[days\]

Sponsor's own description

The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years. The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

DSM265 for Plasmodium falciparum chemoprophylaxis: a randomised, double blinded, phase 1 trial with controlled human malaria infection.
Sulyok M, Rückle T, Roth A, Mürbeth RE, et al · · 2017 · cited 78× · PMID 28363637 · DOI 10.1016/s1473-3099(17)30139-1
Sporozoite immunization: innovative translational science to support the fight against malaria.
Richie TL, Church LWP, Murshedkar T, Billingsley PF, et al · · 2023 · cited 44× · PMID 37571809 · DOI 10.1080/14760584.2023.2245890
A Randomized Trial Evaluating the Prophylactic Activity of DSM265 Against Preerythrocytic Plasmodium falciparum Infection During Controlled Human Malarial Infection by Mosquito Bites and Direct Venous Inoculation.
Murphy SC, Duke ER, Shipman KJ, Jensen RL, et al · · 2018 · cited 43× · PMID 29216395 · DOI 10.1093/infdis/jix613
Recent updates in the discovery and development of novel antimalarial drug candidates.
Okombo J, Chibale K, Chibale K. · · 2018 · cited 38× · PMID 30108934 · DOI 10.1039/c7md00637c
The Promises and Prospects of Long-Acting Therapeutics for Treatment and Prevention of Infectious Diseases.
Olagunju A, Perazzolo S, Stephen ZR, Ryan M, et al · · 2026 · cited 2× · PMID 40956864 · DOI 10.1146/annurev-pharmtox-071724-100739
<i>Plasmodium</i> 18S Ribosomal RNA Biomarker Clearance After Food and Drug Administration-Approved Antimalarial Treatment in Controlled Human Malaria Infection Trials.
Chavtur C, Staubus WJ, Ho M, Hergott DEB, et al · · 2023 · cited 2× · PMID 37265668 · DOI 10.1093/ofid/ofad202
Evaluating the safety, pharmacokinetics, and antiparasitic activity of DSM265, a novel antimalarial plasmodium dihydroorotate dehydrogenase inhibitor: a systematic review and meta-analysis of early clinical trials.
Sula I, Jihwaprani MC, Ahmad I, Khan TA, et al · · 2026 · cited 1× · PMID 41703549 · DOI 10.1186/s12936-026-05826-y
Recent advances, challenges and updates on the development of therapeutics for malaria.
Nandal R, Kumar D, Aggarwal N, Kumar V, et al · · 2024 · cited 1× · PMID 38887396 · DOI 10.17179/excli2023-6856

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Other Medicines for Malaria Venture trials

Trials by the same sponsor.

NCT07011511 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combinati · Phase 1 · recruiting
NCT06558643 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participant · Phase 1 · completed
NCT05361486 — Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru · completed
NCT05930782 — Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers. · Phase 1 · completed
NCT05979207 — Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02562872 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Medicines for Malaria Venture
Last refreshed: 13 January 2022

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/NCT02562872.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing