Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the experimental anti-malarial product, OZ439.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medicines for Malaria Venture
• Collaborator: Queensland Institute of Medical Research
• Treatments: Artefenomel

Criteria

Inclusion Criteria:

• 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 Therapeutic Goods Administration (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 Criteria:

• 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.

• 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 Australian Red Cross Blood Service (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.