Study of the Safety of Intravenous Artesunate

Inclusion Criteria:

- Healthy adult males and non-pregnant, non-lactating females

- Have a normal ECG that may include benign PAC's and PVC's, 1st degree AV block, 2nd
degree AV block, Wenckebach

- Have a normal blood pressure (BP) and heart rate (HR). These will be measured after
resting supine for about 3 minutes. Normal BP is defined as less than 140 mm Hg
systolic and less than 90 mm Hg diastolic. Normal baseline HR is 50 to 90 bpm without
symptoms.

- Body mass index between 18 and 29 kg/m**2 or, if out of range, not clinically
significant (within 15% of their ideal body weight).

- Be able to verbalize understanding of the consent form, provide written informed
consent and verbalize willingness to complete study procedures

- Have a brief physical examination that demonstrates no clinically significant
contraindication for participating in the study.

- If female, have a negative serum pregnancy test at screening and urine pregnancy at
admission or be postmenopausal, had a hysterectomy, been sterilized, or agrees to
practice effective contraception for the duration fo the study and for a period of 12
weeks after stopping study drug.

Exclusion Criteria:

- Have received any investigational drug or vaccine in the period 0 to 16 weeks before
entry to the study.

- Have been on a liquid protein diet in the last year

- Have any clinically significant abnormal physical findings at the screening
examination

- Have any clinically significant abnormalities in the results of laboratory screening
evaluation

- Have used any prescription drugs within 14 days prior to admission or non-prescription
drugs (including herbals or dietary supplements) within 7 days prior to admission

- Existence of any surgical or medical condition that, in the judgement of the clinical
investigator, might interfere with the distribution, metabolism or excretion of the
drug

- Presence of history of drug allergy requiring treatment. Hay fever is allowed unless
it is active or has required treatment within the previous 2 months

- Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before
entry to the study.

- Serious adverse reaction or hypersensitivity to any drug, particularly artemisinins

- CAGE (screening test for alcoholism) positive (2 out of 4 criteria) or has a history
of recent alcohol abuse

- Use of illicit drugs

- Family history of sudden cardiac death or prolonged QT syndrome (defined as 500 msec
noted in repeat tracings)

- History of seizure, syncope, or trouble with hearing or balance or other neurological
disorder

- History of severe psychiatric disorder or hospitalization for severe psychiatric
disorder

- Current job or personal habit of reversed sleep-wake cycle

- History of cardiac disease to include cardiomyopathy, valvular disease, arrhythmia,
ischemia, or enlarged heart

- Presence of hepatitis B surface antigen (Hbs-Ag), hepatitis C antibody (antiHCV) or
HIV type 1 at screening

- Pregnancy