| Eligibility |
Inclusion Criteria:
1. Healthy, adult, male or female (non-lactating) subjects age 18 to 55 inclusive.
2. Good general health, with no significant medical history. Subjects must have no
clinically significant abnormalities on physical examination at screening, and/or
before administration of the initial dose of study drug.
3. Body weight = 50 kg at the screening visit.
4. Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
5. Has laboratory values (clinical chemistry, hematology and coagulation) within the
normal reference range. Deviations from this range may be acceptable if they are
considered 'not clinically significant' (NCS) by the PI.
6. Women of childbearing potential may be enrolled if one of the following criteria
applies:
1. Must be using an effective form of contraception (e.g., oral contraceptives,
vaginal ring, IUD, injected or implanted hormonal contraception) for at least one
month prior to study entry, must have maintained a normal menstrual pattern for
the three months prior to study entry and have a negative pregnancy test (urine)
at the time of admission to the unit. Women must be willing to continue this
contraception for 90 days following administration of study drug. Their male
partner should use a condom.
2. Is sexually abstinent (Investigator judgement)
3. Is monogamous with a vasectomized (by history; see section 4.2) months prior)
4. Is postmenopausal (i.e., amenorrheic for at least 12 months prior to dosing and
demonstrating FSH (follicle-stimulating hormone) consistent with post-menopausal
state
5. negative pregnancy test (urine) both at Screening (serum) and Day -1(urine)
6. Is surgically sterilized (confirmed by medical record review)
7. Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1
(confirmed by medical record review)
7. Males who are sexually abstinent may be enrolled or, if sexually active, may be
enrolled if one of the following criteria applies:
1. Has had a vasectomy (>3 months prior to dosing, by history; see section 4.2)
2. Using condoms and whose partner is using an acceptable form of contraception
(IUD, oral contraceptives, birth control patch or vaginal ring, injectable or
implanted contraceptives, or tubal ligation [surgical sterilization]) from Day -1
to 90 days after study drug administration; using condom with same sex partner
8. Is a light smoker (on average <10 cigarettes/week) or non-smoker and must not have
used any nicotine products within one months prior to dosing. Able and willing to
attend the necessary visits to the study center.
Exclusion Criteria:
1. Blood donation or recipient of blood transfusion in previous 12 weeks.
2. History of clinically significant endocrine, neurological, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases. Cardiovascular history should include
assessment of risk factors for Torsades de Pointes Risk (e.g., heart failure,
pulmonary edema, cardiomyopathy, hypokalemia, hypomagnesemia, or hypocalcemia, or
family history of Long QT Syndrome, syncope or sudden death).
3. History of neoplastic disease (with the exception of adequately treated
non-melanomatous skin carcinoma).
4. Mentally or legally incapacitated (e.g., has significant emotional problems at the
time of Screening Visit or expected during the conduct of the study, or has a history
of a clinically significant psychiatric disorder within the last 5 years).
5. Fever (body temperature >38C) or symptomatic viral/bacterial infection or use of
antibi-otics within 2 weeks prior to Screening.
6. Resting blood pressure (semi-recumbent) (BP) >140/90 mmHg or heart rate (HR) outside
the range 40 to 100 beats per minute at Screening and at Day -1.
7. Clinically significant abnormality on ECG performed at the Screening Visit or prior to
administration of the initial dose of study drug. (Sick sinus syndrome, second or
third degree atrioventricular block, myocardial infarction, symptomatic or significant
cardiac arrhythmia, prolonged QTcF interval, or bundle branch block.
8. Clinically significant laboratory abnormalities including: Impaired renal function
(estimated creatinine clearance (CrCl) of <80 mL/minute based on Creatinine Clearance
Value as determined by the clinical chemistry laboratory. Additionally, subjects with
elevated unconjugated bilirubin consistent with Gilbert's Syndrome are excluded.
9. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human
immunodefi-ciency virus (HIV) antibody at Screening.
10. Participants with a positive toxicology screening panel (urine test including
qualitative identi¬fication of barbiturates, tetrahydrocannabinol, amphetamines,
benzodiazepines, opiates, cocaine and cotinine).
11. Participants with a history of substance abuse or dependency or history of
recreational IV drug use (by self-declaration).
12. Alcohol consumption >21 alcohol units per week. (One unit of alcohol is 10 ml,
information on calculation the content of drinks is provided at: the "alcohol.gov.au"
website.
13. Unable to refrain from or anticipates the use of any medications, including
prescription and non-prescription drugs and herbal remedies (such as St. John's Wort
[Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer)
before administration of the initial dose of study drug and continuing throughout the
study until the follow-up visit. There may be certain medications that are permitted
at the discretion of the Investigator and Sponsor (including
paracetamol/acetaminophen, multi-vitamin preparations, medications for the treatment
of AEs following administration of study drug and immunizations, in particular any one
of the COVID-19 vaccines currently in use in AU).
14. Subjects who are unlikely to comply with the study protocol or, in the opinion of the
inves-tigator, would not be a suitable candidate for participation in the study.
15. Have participated in any other investigational drug trial within 30 days of dosing in
the present study.
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