SJ733 Induced Blood Stage Malaria Challenge Study

Inclusion Criteria

• Adult, male and women of non-child bearing potential (WNCBP as defined in Section 6.17), participants between 18 and 55 years of age inclusive, who do not live alone (from Day 0 until at least the end of the antimalarial drug treatment) and will be contactable and available for the duration of the trial (maximum of 6 weeks).
• Body weight minimum 50.0 kg, body mass index between 18.0 and 32.0 kg/m2, inclusive.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Normal vital signs after 5 minutes resting in supine position:

90 mmHg ≤ systolic blood pressure (SBP) ≤ 140 mmHg, 50 mmHg ≤ diastolic blood pressure (DBP) ≤ 90 mmHg, 40 bpm ≤ heart rate (HR) ≤ 100 bpm.

• Normal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position; QTcF≤450 ms with absence of second or third degree atrioventricular block or abnormal T wave morphology.
• Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy participants enrolled in this clinical investigation in accordance with Sponsor-approved clinically acceptable laboratory ranges documented prior to study start. More specifically for serum creatinine, hepatic transaminase enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless the Participant has documented Gilbert syndrome) should not exceed the acceptable ranges approved by the Sponsor and haemoglobin must be equal or higher than the lower limit of the normal range.
• Male participants must agree to use a double barrier method of contraception including condom plus diaphragm or condom plus IUD or condom plus stable oral/transdermal/injectable hormonal contraceptive by female partner for at least 7 days prior to the time of the first dose of study drug through 90 days after the 5th half-life of the last dose of study drug (half-life of ~20 hours). Abstinent participants have to agree starting a double barrier method if they start sexual relationships during the study and up to 95 days after the last dose of study drug.
• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria

• Any history of malaria or participation to a previous malaria challenge study.
• Must not have travelled to or lived (>2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the study (for endemic regions see http://www.map.ox.ac.uk/browse-resources/).
• Has evidence of increased cardiovascular disease risk (defined as >10%, 5 year risk for those greater than 35 years of age), as determined by the Australian Absolute Cardiovascular Disease Risk Calculator (http://www.cvdcheck.org.au/). Risk factors include sex, age, systolic blood pressure (mm/Hg), smoking status, total and HDL cholesterol (mmol/L) and reported diabetes status.
• History of splenectomy.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician or 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 and non-insulin dependent diabetes (excluding glucose intolerance if E03 is met), 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.
• History of photosensitivity.
• History of G6PD deficiency.
• Participants with history of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, including depression or rece