An experimental study to characterize the effectiveness of OZ439 against early Plasmodium falciparum blood stage infection in healthy volunteers.
Queensland Institute of Medical Research
24 participants
Sep 6, 2012
Interventional
Conditions
Summary
This is a single-center study using a blood stage Plasmodium falcipaurm challenge (BSPC) inoculum to characterize the effectiveness of OZ439 against early Plasmodium falciparum blood stage infection. The study will be conducted in up to 3 cohorts using different doses of OZ439.
Eligibility
Inclusion Criteria7
- Volunteers will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
- Volunteers must have a BMI within the range 18–30.
- Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
- Be contactable and available for the duration of the trial (maximum of 4 weeks).
- Volunteers must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
- Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
- Good peripheral venous access.
Exclusion Criteria12
- History of malaria.
- Travelled to or lived (2 weeks or more) in a malaria-endemic country during the past 12 months or planned travel to a malaria-endemic country during the course of the study. 3) Has evidence of increased cardiovascular disease risk (defined as greater than 10%, 5 year risk)
- History of splenectomy.
- History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy or obsessive compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma.
- Known inherited genetic anomaly (known as cytogenetic disorders) e.g., Down’s syndrome
- Volunteers unwilling to defer blood donations to the ARCBS for 6 months.
- The volunteer has a diagnosis of schizophrenia, severe depression, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis. Participants who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating may be allowed to enroll in the study at the investigator’s discretion. 10) Presence of acute infectious disease or fever (e.g., sub-lingual temperature 38.5 degrees C) within the five days prior to study product administration.
- Evidence of acute illness within the four weeks before trial prior to screening.
- Significant intercurrent disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
- Have ever received a blood transfusion.
- Evidence of any condition that, in the opinion of the clinical investigator, might interfere with the evaluation of the study objectives or pose excessive risks to participants.
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Interventions
This is a single centre study using blood stage Plasmodium falciparum challenge inoculum to characterise the effectiveness of OZ439 against early blood stage Plasmodium Falcipaurm infection.The study will be conducted in up to 3 cohorts (8 particpants in each) using different doses of OZ439. Subsequent cohorts will not commence until at least after day 15 of the previous cohort and review by Safety Review Team following day 14 of the previous cohort. The first dose of OZ439 investigated will be a single dose of 100 mg. Subsequent doses in subsequent cohort(s) will be determined following safety and efficacy data review by the Safety Review Team. It is anticipated that subsequent doses will be between 50-200mg. The drug will be administered orally. OZ439 is the accronym for the drug.
Locations(1)
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ACTRN12612000814875