Conditions: Malaria
Keywords: malaria dose escalation safety tolerability maximum tolerated dose
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 34
Healthy volunteers: yes

Brief summary:
A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:

* To determine the safety and tolerability of ascending doses of OZ439 OD for three days.
* To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.
* To identify the maximum tolerated dose of OZ439 administered.

Detailed description:
This study will be conducted in a randomised, placebo-controlled dose-escalation design with OZ439 OD administered with full fat milk for three days to healthy male and female subjects between 18 to 55 years of age, using features of an adaptive study design. The study is expected to have three cohorts with a total of 36 healthy male and female subjects. An additional two cohorts may be used if required. The results of this study will inform the maximum tolerated exposure of OZ439 following OD dosing for three days in subjects who are not fasted.

Arms:
arm 1: • Cohort 1 (12 subjects: 8 Active \[A\] and 4 on Placebo \[P\]) Active dose will consist of 300mg OZ439 drinking solution administered once daily for 3 days arm 2: • Cohort 2 (12 subjects: 8 A, 4P). Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days arm 3: Cohort 3 (12 subjects: 8 A, 4P). Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days

Interventions: intervention 1: OZ439
Intervention descriptions: intervention 1: OZ439 x mg once daily for 3 days with milk

Protocol document: