An experimental study to characterize the effectiveness of OZ439 against early Plasmodium falciparum blood stage infection in healthy volunteers.

Phase 2

Completed

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12612000814875
• Lead Sponsor: Queensland Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. 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).
2. Volunteers must have a BMI within the range 18–30.
3. Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
4. Be contactable and available for the duration of the trial (maximum of 4 weeks).
5. Volunteers must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
6. 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.
7. Good peripheral venous access.

Exclusion Criteria

1) History of malaria.
2) 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)
4) History of splenectomy.
5) History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
6) 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.
7) Known inherited genetic anomaly (known as cytogenetic disorders) e.g., Down’s syndrome
8) Volunteers unwilling to defer blood donations to the ARCBS for 6 months.
9) 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.
11) Evidence of acute illness within the four weeks before trial prior to screening.
12) 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.
13) Have ever received a blood transfusion.
14) 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic-pharmacodynamic relationship of OZ439 on clearance of Plasmodium falciparum parasites from the blood in healthy volunteers following infection with blood stage parasites. This outcome will be assessed by measuring drug levels and parasite levels and assessing changes in both.[30 Days]

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of OZ439 in healthy volunteers following infection with blood stage Plasmodium falciparum. This outcome will be assessed by measuring drug levels in blood.[6 days];To assess the tolerability ofOZ439 in the experimental malaria challenge system. This outcome will be measured by soliciting adverse events in volunteers, and by blood laboratory safety tests, including biochemistry and haematology screen, viral and infectious disease serology, and red cell alloantibody screen.[30 days]