A Phase 2 interventional study of INE963 in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in 6 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.
The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).
Exclusion Criteria:
Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
Other protocol-defined inclusion/exclusion criteria may apply.
Cohort A1: INE963 Dose Level 1
Drug: INE963
Cohort A1: INE963 Dose Level 2
Drug: INE963
Cohort A1: INE963 Dose Level 3
Drug: INE963
Cohort A1: INE963 Dose Level 4
Drug: INE963
Administered via oral INE963
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Time frame: up to Day 7
PCR-corrected and uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as monotherapy in participants with uncomplicated P. falciparum malaria.
Time frame: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Maximum observed concentration (Cmax)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Time to reach maximum observed concentration (Tmax)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Elimination half-life (T1/2)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Total body clearance (CL/F)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Apparent volume of distribution (V/F)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Area under the concentration-time curve (AUC0-t)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals