Inclusion Criteria:
1. Healthy adult male or female participants between 18 and 55 years of age
(inclusive).
2. Body weight between 45 and 100 kg (inclusive) and body mass index (BMI) within 18~32
kg/m2 (inclusive).
Health status. 3. In good health as determined by screening tests. Good health is defined as having no
clinically relevant abnormalities identified by a detailed medical history, full
physical examination (including measurement of blood pressure and pulse rate),
12-lead Electrocardiograph (ECG), and clinical laboratory tests.
- - Vital signs (measured after resting for 5 minutes semi-supine position) within
a normal range of the clinical site,, or outside the normal range and not
considered clinically significant by the Investigator.
- - Standard 12-lead Electrocardiograph (ECG) parameters (recorded after resting
for 5 minutes in semi-supine position) in the following ranges; QTc (Fridericia
algorithm recommended) ≤ 450 ms for males and 470 ms for females, and normal
ECG tracing, or abnormal ECG tracing not considered clinically relevant by the
Investigator.
- - Laboratory parameters demonstrating no clinically significant abnormalities, as
determined by the Investigator.
Total bilirubin outside the normal range may be
acceptable if total bilirubin does not exceed 1.5x ULN with normal conjugated
bilirubin (with the exception of a patient with documented Gilbert syndrome).
4. A negative result on urine drug screen and a repeat negative result on Day -1
(amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids,
cocaine, opiates).
5. Female participants must not be pregnant or breastfeeding and must use an effective
contraception method with the exception of participants who have undergone
sterilization more than 3 months prior to screening or who are postmenopausal.
A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to
the first dose of the study drug. The participant must be excluded from the study if
the serum pregnancy test is positive.
A postmenopausal state is defined as 12 months of amenorrhea without an alternative
medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed
by follicle stimulating hormone (FSH) measurement (> 40 IU/L or mIU/mL).
Females on HRT (Hormonal Replacement therapy), where menopausal status is
indeterminate, will be required to use a non-estrogen hormonal contraceptive method
if participants wish to continue their HRT during the study. Participants must
otherwise discontinue HRT to allow for confirmation of postmenopausal status prior
to enrollment in the study.
6. Provide written informed consent prior to undertaking any study-related procedures.
7. Must not be under any administrative or legal supervision or under
institutionalization as per a regulatory or juridical order.
Exclusion Criteria:
1. Any history or presence of clinically relevant cardiovascular, pulmonary,
gastrointestinal, hepatic, renal, metabolic, hematological, neurological,
musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious
disease, or signs of acute illness.
2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting
(defined as vomiting more than twice a month).
3. Made a blood or plasma donation of ≥500 ml within 1 month prior to the first dose.
4. Demonstrated clinically significant (required intervention, e.g., emergency room
visit, epinephrine administration) allergic reactions, which in the opinion of the
Investigator, would interfere with the volunteer's ability to participate in the
trial.
5. Known hypersensitivity to any component of the IMP formulation.
6. History or presence of drug or alcohol abuse (defined as alcohol consumption of more
than 2 units per day on a regular basis).
7. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or
unable to stop smoking during the study. Occasional smokers may be enrolled but need
to abstain during admission to the site. 8. Excessive consumption of beverages containing xanthine bases (defined as more than 4
glasses per day).
9. Any medication, including St John's Wort, within 14 days prior to administration of
the first dose or within 5 times the elimination half-life or pharmacodynamic
half-life of the medication, with the exception of hormonal contraception,
menopausal hormone replacement therapy, or occasional paracetamol at doses up to
2g/day.
10. Any consumption of grapefruit or products containing grapefruit within 5 days prior
to the first dose administration.
11. Any vaccination in the 2 weeks prior to administration of the first dose (Covid19
vaccination included, and planned COVID19 vaccinations, including booster shots,
during the study or for 2 weeks after the last dose of the study drug)
12. Any participant who, in the judgment of the Investigator, is likely to be
non-compliant during the study, or to be unable to cooperate due to language
problems or poor mental development.
13. Any participant who enrolled in or participated in any other clinical study
involving an investigational medicinal product, or in any other type of medical
research within 1 month or within 5 times the elimination half-life prior to
administration of the first dose.
14. Any participant who cannot be contacted in the case of an emergency.
15. Any participant who is the Investigator or any subinvestigator, research assistant,
pharmacist, study coordinator, or other staff thereof directly involved in
conducting the study or any person dependent on (employees or immediate family
members) the study site, the Investigator or the Sponsor.
Biological status. 16. Positive result on any of the following tests: hepatitis B surface antigen (HbsAg),
hepatitis B core antibodies (HbcAb), anti-hepatitis C virus antibodies (anti-HCV),
anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
17. Positive alcohol test at D-1.
18. Any participant in whom venous blood collection is difficult.
