Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers
Condition: Malaria
MeSH terms: Malaria
Intervention: OZ439
Intervention description: OZ439 Powder for Oral Suspension
Intervention MeSH terms: Artefenomel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.