Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria

NCT07235020 | Completed Phase 2 DMC

• 1 other identifier: CADPT13A12201_A1
• Study Type: interventional
• Target: 52
• Locations: 6 countries
• Sites: 6

Brief Summary

This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.

Conditions

Uncomplicated Plasmodium Falciparum Malaria

Keywords

single dose cure malaria; uncomplicated malaria; Plasmodium falciparum; platform study; PLATINUM

Outcome Measures

Primary Outcomes (1)

• 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.

  up to Day 7

Secondary Outcomes (9)

• PCR-corrected and uncorrected ACPR

  Day 29

• Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)

  Day 22

• Area under the concentration-time curve from time zero to infinity (AUCinf)

  Day 22

• Maximum observed concentration (Cmax)

  Day 22

• Time to reach maximum observed concentration (Tmax)

  Day 22

Study Arms (4)

Cohort A1: INE963 Dose Level 1

EXPERIMENTAL

Cohort A1: INE963 Dose Level 1

Drug: INE963

Cohort A1: INE963 Dose Level 2

EXPERIMENTAL

Cohort A1: INE963 Dose Level 2

Drug: INE963

Cohort A1: INE963 Dose Level 3

EXPERIMENTAL

Cohort A1: INE963 Dose Level 3

Drug: INE963

Cohort A1: INE963 Dose Level 4

EXPERIMENTAL

Cohort A1: INE963 Dose Level 4

Drug: INE963

Interventions

INE963 DRUG

Administered via oral INE963

Cohort A1: INE963 Dose Level 1; Cohort A1: INE963 Dose Level 2; Cohort A1: INE963 Dose Level 3; Cohort A1: INE963 Dose Level 4

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ≥18 years of age at screening.
• Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum
• Patients must weigh between 40 kg and 90 kg.
• Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.

You may not qualify if:

• Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
• Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
• 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:
• AST/ALT \> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
• AST/ALT \> 1.5 and ≤ 2 x ULN and total bilirubin is \> ULN
• Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT
• Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
• Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
• History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
• Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
• History of familial long QT syndrome or known family history of Torsades de Pointe.
• Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Banfora, Burkina Faso

Location

Novartis Investigative Site

Azaguié, BP 173, Côte d’Ivoire

Location

Novartis Investigative Site

Lambaréné, BP 242, Gabon

Location

Novartis Investigative Site

Navrongo, VWJ6+8WF, Ghana

Location

Novartis Investigative Site

Kisumu, 40100, Kenya

Location

Novartis Investigative Site

Kampala, Uganda

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

INE963

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 23, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 21, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

KE (1); GA (1); UG (1); CÔ (1); BU (1); GH (1)