| Eligibility |
Inclusion Criteria:
1. Must be 18 to 50 years inclusive, at the time of signing informed consent.
2. Capable of giving signed informed consent as described in the protocol which includes
compliance with the requirements and restrictions listed in the informed consent and
in the protocol in the opinion of the investigator.
3. Subjects who are healthy as determined by medical evaluation including medical
history, physical examination, cardiac monitoring using 12-lead ECG, and laboratory
tests in the opinion of the investigator.
4. Female or male
a. Female subjects i. A female subject is eligible to participate if
- of non-childbearing potential defined as premenarchal, or premenopausal with
documented (subject's self-report) bilateral tubal ligation or occlusion,
bilateral oophorectomy, bilateral salpingectomy, or hysterectomy; or
- postmenopausal, documented as 12 months of spontaneous amenorrhea prior to Day 1,
and in questionable cases, a blood sample at screening with simultaneous follicle
stimulating hormone (FSH) consistent with postmenopausal status (refer to
laboratory reference ranges for confirmatory levels); or
- of childbearing potential, not pregnant, not lactating and agrees to use one of
the following acceptable methods of contraception until 30 days after the last
dose of study drug:
- total abstinence from sexual activities, or
- double barrier method, or
- an intrauterine device or system, or
- established use of hormonal contraceptives including oral, implantable,
injectable or transdermal contraceptives.
b. Male subjects i. Male subjects with female partners of childbearing
potential must comply withthe following contraception requirements from the
time of study drug until90 days after the last dose of study drug
administration.
- total abstinence, or
- vasectomy with documentation (subject's self-report) of azoospermia 90 days prior
to Day 1 (without reversal surgery), or
- barrier form of contraception (condom), and
- female partner established user of an intrauterine device/system or hormonal
contraceptives including oral, implantable, injectable or transdermal
contraceptives.
ii. Male subjects must also agree not to donate sperm until 90 days after dosing.
5. Women of childbearing potential must have a negative serum pregnancy test at screening
and a negative urine pregnancy test on Day -1.
6. Has venous access sufficient to allow for blood sampling.
7. Has a body mass index (BMI) within the range of greater than or equal to 18.0 kg/m2
and less than or equal to 35 kg/m2, and, in the opinion of the investigator, the
subject's body habitus would not preclude the ability to correctly inject
intramuscularly at the site of injection.
8. Has a maximum body weight of 120 kg.
9. Agrees to abstain from strenuous exercise for 1 week before study Day -1 and during
confinement.
Exclusion Criteria:
1. Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, infectious, cardiovascular,
gastrointestinal, neoplastic (except for basal or squamous cell cancer), neurological,
or psychiatric disorder (as determined by the Investigator) capable of significantly
altering the absorption of drugs; of constituting a risk when taking the study
medication; or of interfering with the interpretation of the data.
2. Any major surgical procedure or hospitalization within 6 months prior to Day -1 or
during the study, unless deemed not clinically significant by the Investigator.
3. A history of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance, unless approved by the Investigator.
4. History or presence of an abnormal ECG which, in the Investigator's opinion, is
clinically significant. A QTc interval duration Fridericia greater than 450 ms
obtained as an average from triplicate screening ECGs after at least 10 minutes rest
at screening.
5. Systolic blood pressure greater than 140 mmHg or a diastolic blood pressure of greater
than 90 mmHg after approximately 10 minutes rest at screening.
6. Calculated glomerular filtration rate of less than 60 mL/min/1.73m2 by estimated
glomerular filtration rate (eGFR) using standardized local clinical methodology.
7. History of alcohol or other substance disorders within 1 year prior to screening, or
recent use of drugs of abuse or a positive urine screen for drugs of abuse at
screening in the opinion of the Investigator.
8. History of depression or suicidal thoughts and/or behaviors within 1-year prior to
screening in the opinion of the Investigator and assessed by S-STS at screening.
9. Has an average weekly alcohol intake that exceeds 10 units per week within 30 days
prior to screening. One unit: 1 glass of wine 5 oz or 150 mL; 12 oz or 360 mL of beer;
1.5 oz or 45 mL of distilled spirits.
10. Are unwilling to stop alcohol consumption within 72 hours prior to Day -1 (as
confirmed by alcohol breath screen test) and for the duration of the study.
11. Use any tobacco- or nicotine-containing products including, but not limited to
cigarettes, electronic cigarettes (of any kind), pipes, vapes, cigars, chewing
tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior
to screen, Day -1 (as confirmed by cotinine testing), and during the study.
12. Positive drug testing at screening and/or at Day -1. Subjects should refrain from
eating poppy seed-containing food (e.g., poppy cake) at least 3 days before admission
as this can falsify the urine drug screen.
13. History of intolerance to IM injection.
14. Any conditions which, in the opinion of the Investigator, would make the subject
unsuitable for enrollment or could interfere with the subject's participation in or
completion of the study.
15. Donated more than 500 mL of blood within 90 days before study drug administration.
16. History of clinically significant chronic liver disease from any cause, presence of
hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency
virus antibody.
17. History of hepatic decompensation, including ascites, hepatic encephalopathy and/or
esophageal or gastric varices.
18. Positive COVID test on Day -1 (test conducted as per site standard procedures).
19. Is unable to refrain from or anticipates the use of any medication, including
prescription and non-prescription drugs or herbal remedies (e.g., St. John's wort,
milk thistle) or supplement supra-therapeutic doses of vitamins within 14 days (or 5
half-lives, whichever is longer) prior to Day 1 and throughout the study, except for
those approved by the Investigator, Medical Monitor, and/or Brii Biosciences.
20. Use of antiplatelet, anticoagulant, or antiepileptic medications within 30 days prior
to Day 1 and throughout the study.
21. Use of oral hypoglycemics, diuretics and uricosurics, antidepressants, opioids or
centralnervous system acting drugs, such as benzodiazepines, within 14 days before Day
1 andthroughout the study.
22. Consumption of foods or juices containing cranberries or pineapples, Seville
oranges,grapefruit, pomegranate or caffeine (xanthine-containing products) within 72
hours priorto Day 1 and throughout the study, unless deemed acceptable by the
Investigator.
23. The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days or 5 half-lives of the investigational product (whichever is longer).
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