NCT05205941

MMV533 Plasmodium Falciparum Volunteer Infection Study

A Phase 1b Study to Assess the Safety, Tolerability and Antimalarial Activity of MMV533 Against Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1b study to assess the safety, tolerability and antimalarial activity of MMV533 against Plasmodium falciparum 3D7 blood stage infection in healthy volunteers

Detailed description

The study will characterise the effects of single oral doses of MMV533 on the clearance of Plasmodium falciparum 3D7 using the Induced Blood Stage Malaria (IBSM) model. This is a well-established method for obtaining useful pharmacokinetic-pharmacodynamic (PK-PD) information on anti-malarial drugs. The study will be an open-label, pilot Volunteer Infection Study (VIS) using the IBSM model and single dose IMP. The study will be conducted in healthy malaria-naive adult volunteers infected with Plasmodium falciparum 3D7, in one cohort of approximately 12 volunteers (all receiving active treatment). From an operational perspective, the full cohort may be conducted in subgroups of up to 6 volunteers. Ascending doses will be administered in order of enrolment number (per sub-group, if applicable). Volunteers will be enrolled within a 28 day screening period to ensure volunteers meet all the inclusion criteria and none of the exclusion criteria. On Day -8 (8 days prior to IMP administration), volunteers will attend the clinical unit to be inoculated with the malaria challenge agent containing approximately 2,800 viable human erythrocytes infected with P. falciparum 3D7 parasites. Parasitaemia will be monitored on an outpatient basis daily on Day -4, and then twice daily on Day -3, Day -2 and until admission to the clinical unit on Day -1 for eligibility check and confinement. Volunteers will be administered IMP on Day 1 and will have safety monitoring and blood sampling for parasitaemia monitoring and PK analysis on an inpatient basis for at least 108 hours post-IMP administration. Volunteers will be discharged from the clinical unit after review of ECG, vital signs, clinical and laboratory tests safety data by the Principal Investigator or delegate, and will then attend the clinical unit on an outpatient basis regularly for continued safety monitoring and blood sampling for parasitaemia monitoring and PK analysis. Volunteers will be administered mandatory malaria rescue medication at Day 21±3, or earlier if there is failure to clear parasites or recrudescence and at the discretion of the Principal Investigator or delegate. EOS will be on Day 28±3. Volunteers must have had at least two negative 18S qPCR (18 Svedberg quantitative polymerase chain reaction) results prior to EOS and must have completed their course of anti-malarial rescue medication. In the event of recrudescence, blood samples will be collected prior to rescue treatment to culture parasites for drug resistance testing.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	MMV688533	Not exceeding 200mg

Timeline

• Start date: 2022-03-30
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2022-01-25
• Last updated: 2024-12-02
• Results posted: 2024-12-02

Locations

1 site across 1 country: Australia