New malaria pill tested in humans for first time
NCT ID NCT06171113
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This early-stage trial is testing a new drug called GSK4024484 in 156 healthy adults to see if it is safe and how the body handles it. Researchers will also check if food affects the drug. The goal is to gather safety information before testing it in people with malaria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GSK4024484
- What this could lead to
- If this early study shows the drug is safe, it could lead to larger trials testing whether GSK4024484 can treat or prevent malaria.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not patients. The drug may prove unsafe or ineffective in later studies. Side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
123 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent. 2. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment. 3. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the Investigator considers, that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints. 4. ALT (Alanine transaminase) and AST (Aspartate transaminase) within the normal range at screening. 5. Total bilirubin within the normal range unless the participant is known to have Gilbert's syndrome. 6. Body weight ≥50kg, and BMI within the range 19 to 32 kilogram per square metre (kg/m\^2) inclusive. 7. Male participants and female participants who are not of child bearing potential. 8. The participant is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Exclusion Criteria: 1. History or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data in the opinion of the investigator. 2. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 3. An average weekly alcohol intake of \>14 units a week within 6 months prior to the study. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits. 4. QTcF (Fridericia's formula) \>450 msec based on average of triplicate ECGs. The QTcF is the QT interval corrected for heart rate according to QTcF. 5. More than 100 ventricular ectopic complexes in 24 hrs by Holter screening or any other clinically significant Holter abnormalities determined by the investigator. 6. Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. 7. Heart rate \<40 or \>100 beats per minute (bpm). 8. Evidence of previous myocardial infarction or any clinically significant conduction abnormality such as (including but not specific to left complete bundle branch block, AV block \[2nd degree or higher\], WPW syndrome). Long standing RBBB is permitted. 9. Past or intended use of over-the-counter or prescription medication, including herbal medications, CBD-based products, PPIs or H2 antagonists within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longest) prior to dosing. Other concomitant medication may be considered on a case by case basis by the investigator in consultation with the medical monitor. Paracetamol is permitted (capped at ≤2 grams/day). 10. Participation in the study that would result in loss of blood or blood products in excess of 500 mL within a 56-day period. 11. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. 12. Current enrolment or past participation (within the last 30 days before planned first dose in this study) in any other clinical study involving an investigational study intervention or any other type of medical research. 13. Participants previously dosed in this study. 14. Presence of HBsAg \[or HBcAb\] at screening or within 3 months prior to first dose of study intervention. 15. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. 16. Positive hepatitis C RNA (ribonucleic acid) test result at screening or within 3 months prior to first dose of study intervention. 17. Positive pre-study drug/alcohol screen. 18. Positive HIV antibody test. 19. Carbon monoxide levels indicative of smoking or more than 10 pack year history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. 20. Use of known recreational drugs or drugs of abuse. 21. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in the study. 22. A positive confirmation of COVID-19 infection according to local procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
GSK Investigational Site
Cambridge, CB2 0GG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental malaria vaccine aims to block parasite growth
- New malaria drug interaction study launches in healthy volunteers
- New malaria shots could replace daily pills
- New malaria antibody enters first human safety tests
- Breastfeeding moms with malaria: do drugs reach baby?
- New malaria pill shows promise in early trial