A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. … (NCT07545681) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
70 participantsStarted 2026-04-20
Plain-language summary
The study will evaluate the safety and efficacy of a new antimalarial drug GSK3772701 (a pyrrolidinamide), using different doses and treatment durations, in adult participants with uncomplicated Plasmodium (P.) falciparum malaria.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients aged 18 to 65 years.
* Presence of malaria due to mono-infection with P. falciparum confirmed by:
* Fever, as defined by axillary temperature \>=37.5°C or oral/tympanic temperature \>=38°C and,
* Microscopically confirmed P. falciparum malaria parasite mono-infection,
* A parasite count between 2,000 to 60,000 asexual parasite count/µL of blood for P. falciparum.
* Have a BMI between \>=18 and \<=30 kg/m2.
* Able to swallow oral medication.
* Signed informed consent, acknowledging understanding and willingness to comply with the requirements of the study. If the patient is unable to write, thumb print consent, signed by an impartial witness is permitted according to local ethical considerations.
* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a woman of non-childbearing potential (WONCBP) or
* Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method, from Study Day 1, and during the study intervention period (40 +/-3 days).
Exclusion Criteria:
* Patients with signs and symptoms of severe/complicated malaria according to the WHO 2024 Criteria.
* Mixed Plasmodium infection, i.e., infection with more than one malaria (plasmodium) species (b…
What they're measuring
1
Number of participants with serious adverse events (SAEs) overall, treatment related, and by severity
Timeframe: From the date of informed consent signing (up to 24 hours prior to Day 1) up to Day 40 (end of the follow-up period)
2
Number of participants with non-serious AEs overall, treatment related, and by severity