MedTrace Logo

First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants

NCT03261401 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-10-16

Study results available
· View outcomes & findings →

Summary

The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants following infection with Plasmodium falciparum.

Conditions

  • Healthy

Interventions

DRUG

M5717

Participants received single ascending oral dose of M5717 after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast

DRUG

Placebo

Participants received placebo matched to M5717

DRUG

M5717

Participants received single ascending oral dose of M5717 from Part A after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2019-06-14
Completion
2019-06-14

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03261401 on ClinicalTrials.gov