| Eligibility |
Inclusion Criteria:
- 1. Male or female 18 to 55 years of age, inclusive. 2. Ability to understand and
willingness to sign a written informed consent form.
3. Healthy as determined by medical history, physical examination, laboratory
parameters, vital signs, and ECG at Screening and Check-in.
4. Body mass index (BMI) =18.0 to =32.0 kg/m2 and body weight >50 kg (males) or >45 kg
(females) at Screening.
5. If a female, must be:
- Postmenopausal, defined as amenorrhea for at least 12 months, and confirmed by
serum follicle stimulating hormone (FSH) and estradiol levels at Screening, OR
- Surgically sterile with a documented hysterectomy, partial hysterectomy,
bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to
Screening, OR
- If of child-bearing potential, sexually active females with male partners must be
using an acceptable method of contraception such as an intrauterine device,
implant or contraceptive injection, or two forms of the following (e.g.,
diaphragm, cervical cap, patch or vaginal hormonal contraceptive, condom,
spermicide, or sponge) for the last three months, and agree to continue to use
their method of birth control for the duration of the study and for a minimum of
one complete menstrual cycle after study completion. If a female subject is
abstinent, she must agree to use an acceptable form of birth control once she
become sexually active during the study.
6. If a female of child-bearing potential, must have a negative pregnancy test
result at Screening and Check-in.
7. If a male, if sexually active with a female partner of child-bearing potential
and has not had a vasectomy, must agree to use a highly effective double barrier
method of contraception as deemed appropriate by the Investigator and must not
donate sperm during the study and for 3 months after the last dose of study drug.
8. Non-smokers or light-smoker (less than 10 per week)(including
nicotine-containing products) for at least 6 continuous months prior to the first
dose by subject report.
9. Willingness and ability to comply with study procedures and follow-up
examination.
Exclusion Criteria:
- 1. Reported history of or current clinically significant medical illness including but
not limited to cardiac, hepatic, renal, respiratory, gastrointestinal, endocrine,
immunologic, dermatologic, hematologic, neurological (e.g. history of epileptic
seizures), or psychiatric disease.
2. Reported history or presence of pro-arrhythmic conditions, including a marked
baseline prolongation of QTc interval (i.e., repeated demonstration of a QTcF interval
>450 milliseconds) or a history of additional significant risk factors for torsade de
pointes (e.g., family history of long QT syndrome), including any evidence of QTcF
prolongation at screening.
3. Reported epileptiform discharges in the sleep-deprived EEG during screening. 4.
Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at Screening or Check-in as deemed by the Investigator.
5. Systolic blood pressure > 140 mm Hgand/or diastolic blood pressure > 90 mmHg or
systolic blood pressure < 90mmHg and/or diastolic blood pressure < 50mmHg at
Screening, and determined by the Investigator to confer a safety risk to the subject.
Blood pressure measurements may be repeated after at least 10 minutes of rest if
initial values obtained at Screening or Check-in are exclusionary.
6. Subjects with active pathogen infections or carrier including but not limited to
testing positive at Screening for human immunodeficiency virus (HIV), Hepatitis B
surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
7. Subjects with a positive test result for Coronavirus disease 2019 (COVID-19) at
Check-in.
8. Donated blood or blood product or had substantial loss of blood (more than 500 mL)
within 1 months prior to Screening.
9. Use of any prescription or non-prescription drugs (including vitamins and herbal
supplements) within 7 days prior to the first dose of study drug and throughout the
study. Use of the following medication will be allowed during the study: acetaminophen
(up to 1000 mg per 24 hours at the discretion of the Investigator).
10. Reported history and/or recent evidence (within 12weeks prior to the Screening) of
alcohol abuse (e.g., for females, 4 or more drinks during a single occasion, or 8 or
more drinks per week, and for males, 5 or more drinks during a single occasion, or 15
or more drinks per week), or other drug/substance use disorder.
11. Positive test result for alcohol and/or drugs of abuse at Screening or Check-in.
12. Known allergy or hypersensitivity to CB03-154 or any of excipients of CB03-154
tablet formulation.
13. Received an experimental drug or used experimental medical device within 3 months
or within 10 half-lives of the drug, whichever is longer, prior to the first dose of
study drug.
14. Any condition or disorder that in the Investigators' opinion would put the subject
or study conduct at risk if the subject were to participate in the study.
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