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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-02-21

Brief Summary

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

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Detailed Description

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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).

Conditions

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Uncomplicated Plasmodium Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This study is open-label study.

Study Groups

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Cohort A1: INE963 Dose Level 1

Group Type EXPERIMENTAL

INE963

Intervention Type DRUG

Administered via oral INE963

Cohort A1: INE963 Dose Level 2

Group Type EXPERIMENTAL

INE963

Intervention Type DRUG

Administered via oral INE963

Cohort A1: INE963 Dose Level 3

Group Type EXPERIMENTAL

INE963

Intervention Type DRUG

Administered via oral INE963

Cohort A1: INE963 Dose Level 4

Group Type EXPERIMENTAL

INE963

Intervention Type DRUG

Administered via oral INE963

Interventions

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INE963

Administered via oral INE963

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients ≥18 years of age at screening.
2. 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
3. Patients must weigh between 40 kg and 90 kg.
4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.

Exclusion Criteria

1. 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
2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
3. 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
4. Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
5. 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.
6. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No