This is a single-centre, open-label, study using induced blood stage malaria (IBSM) infection
to characterize the activity of (+)-SJ000557733 or SJ733 for short, against early Plasmodium
falciparum blood stage infection. The study will be conducted in two cohorts (n=8 per
cohort). The anticipated efficacious dose range is expected to be within a range of 125 to
600 mg. The dose used in the first cohort was determined on the basis of the safety and PK
data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and
will be 150 mg. Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia)
obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600
mg. Based on the PK from all three cohort from the FIM study, the median estimated dose to
obtain the target SJ733 AUC of 13,000 (ug hr/L) is 370 mg. The dose of cohort 2 (≤600mg) is
intended to provide further concentration-response information in the human challenge model.
For Cohort 2 only, a second dose of SJ733 may be administered at peak gametocytaemia to
assess if SJ733 can reduce gametocytes and subsequent infectivity to mosquitoes (a washout of
~15 days post initial SJ733 treatment will be observed). Depending on the data obtained from
the first two cohorts, there may be a subsequent cohort, with the investigated dose of SJ733
to be determined by the Sponsor and Principal Investigator (PI) and endorsed by the Safety
Review Team. Should this third dose be investigated, a substantial amendment including
preliminary data from the first two cohorts will be submitted to the HREC for approval.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Clinical Network Services (CNS) Pty Ltd Q-Pharm Pty Limited QIMR Berghofer Medical Research Institute