Pyronaridine in Healthy Adult Participants Infected With Blood Stage Malaria

Summary

This is an open-label, adaptive study that will utilise the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile of pyronaridine. Up to 18 healthy, malaria naïve adult participants are planned to be enrolled into this study, in cohorts of up to six participants each. Following a screening period of up to 28 days, cohorts of up to 6 healthy participants will be enrolled. Each participant will be inoculated intravenously on Day 0 with P. falciparum infected erythrocytes. Participants will be followed up daily on Days 1 to 3, and will attend the clinical unit once on Days 4, 5, 6 and 7 for clinical evaluation and blood sampling. Participants will be admitted to the clinical trial unit on Day 8 for a single oral dose of pyronaridine.

Different doses of pyronaridine will be administered across and within cohorts. Participants will be randomised to a dose group on the day of dosing. The highest dose of pyronaridine administered will be no more than 720 mg; the lowest dose administered will be no less than 180 mg.

Each subsequent cohort will be composed of up to 3 dose groups. The Safety Data Review Team (SDRT) will review all available safety and tolerability data from the previous cohort/s prior to inoculation of the next cohort.

Participants will be confined in the clinical unit for at least 96 h (Days 8 - 12) to monitor the safety and tolerability of pyronaridine dosing. Upon discharge from the clinical unit participants will be monitored on an outpatient basis up to Day 50±2. Participants will receive compulsory antimalarial rescue treatment with Riamet® (artemether/lumefantrine) on Day 47±2 or earlier.

Conditions

• Malaria,Falciparum
• Malaria
• Malaria Recrudescence
• Parasitemia
• Protozoan Infections
• Parasitic Disease

Interventions

DRUG

Pyronaridine

Single dose

BIOLOGICAL

P. falciparum IBSM infection

Induced Blood Stage Malaria

Sponsors & Collaborators

• QIMR Berghofer Medical Research Institute

  collaborator OTHER

• Southern Star Research

  collaborator INDUSTRY

• Swiss BioQuant

  collaborator INDUSTRY

• Children's Health Queensland Hospital and Health Service

  collaborator UNKNOWN

• Medicines for Malaria Venture

  lead OTHER

Principal Investigators

• Jörg Möhrle, PhD · Medicines for Malaria Venture

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2022-09-26

Completion

2022-09-26

Countries

• Australia

Study Locations