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Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

NCT03334747 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2021-10-11

Study results available
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Summary

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.

Conditions

Interventions

DRUG

KAE609

Exploration of different doses of KAE609 to establish safety profile.

DRUG

Coartem

Control Arm

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2019-11-23
Completion
2019-11-23

Countries

  • Gabon
  • Ghana
  • Mali
  • Rwanda
  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03334747 on ClinicalTrials.gov