| Eligibility |
Inclusion Criteria:
1. Provision of signed and dated informed consent prior to any study specific procedures
2. aged 20 to 45 years, inclusive, at the time of screening
3. male subjects: agree to use an effective method of contraception and not donate sperm
for the duration of the study and for 3 months following the last dose of ABSK091
4. female subjects: non-pregnant, non-lactating female subjects who if premenopausal are
using adequate birth control, e.g., oral, injectable, transdermal or implanted
hormonal contraceptives, vaginal contraceptive ring, intrauterine device/intrauterine
system, tubal ligation, vasectomized sexual partner (with confirmed negative sperm
counts) or true sexual abstinence. All females must have a negative serum pregnancy
test within 7 days and a negative urine pregnancy test within 24 hours prior to dosing
with ABSK091
5. have a body mass index (BMI) of 18.5 to 24.9 kg/m2, inclusive, and weigh at least 50
kg and no more than 90 kg, at screening
6. healthy subjects as determined by medical history and physical examination and have
clinical laboratory test results within normal reference range for the investigative
site, or results with acceptable deviations that are judged to be not clinically
significant by the investigator
7. with suitable veins for cannulation or repeated vein puncture
8. are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures
Exclusion Criteria:
1. Are currently enrolled in a clinical trial involving an investigational product or any
other type of medical research judged not to be scientifically or medically compatible
with this study
2. Have participated, within the last 30 days, in a clinical trial involving an
investigational product. If the previous investigational product has a long half-life,
3 months or 5 half-lives (whichever is longer) should have passed.
3. Have previously completed or withdrawn from this study or any other study
investigating ABSK091, and have previously received the investigational product
4. Have a history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs; of
constituting a risk when taking the investigational product; or of interfering with
the interpretation of data, in the opinion of the Investigator, may either put the
subject at risk because of participation in the study, or influence the results or the
subject's ability to participate in the study.
5. Have known allergies to ABSK091, related compounds, or any components of the
formulation, or history of significant atopy.
6. Have known or ongoing psychiatric disorders that would interfere with study
participation as determined by the investigator.
7. Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of ABSK091 .
8. Any clinically significant abnormalities in clinical chemistry, hematology, or
urinalysis results as judged by the Investigator.
9. Have an abnormality in the 12-lead ECG that, in the opinion of the investigator,
increases the risks associated with participating in the study.
10. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) >450
ms (female >480 ms) or shortened QTcF <350 ms or family history of long QT syndrome.
11. Have an abnormal blood pressure as determined by the investigator.
12. Any positive result on screening for serum hepatitis B surface antigen (HBsAg),
hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) .
13. Any of the following ophthalmological criteria.
14. Known or suspected history of drug abuse as judged by the Investigator.
15. Have used or intend to use over-the-counter or prescription medication , including
herbal medications, within 14 days prior to dosing and during the study
16. Plasma donation within one month of screening or any blood. donation/blood loss >500
mL during the 3 months prior to screening
17. Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
units per week (females), or are unwilling to abide by alcohol restrictions as
specified in Section 6.3.2 (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine;
1.5 oz or 45 mL of distilled spirits)
18. are subjects who currently smoke more than 5 cigarettes per day (or equivalent in
tobacco or nicotine products) or are unwilling to abide by smoking restrictions as
specified in Section 6.3.2
19. Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade
or other products containing grapefruit or Seville oranges within 7 days before the
first administration of the ABSK091
20. have a current or recent history (<30 days prior to screening and/or <45 days prior to
Day -1 in Period 1) of a clinically significant bacterial, fungal, parasitic, viral
(not including rhinopharyngitis), or mycobacterial infection
21. have had symptomatic herpes zoster within 3 months of screening
22. have received live vaccine(s) within 3 months of screening, or intend to during the
study
23. are unwilling to comply with the dietary requirements/restrictions during the study.
24. have used or intend to use drugs or substances that are known to be strong or moderate
inhibitors or inducers of CYP 3A4/5 and/or CYP2D6 within 30 days prior to the first
dose and throughout the study.
25. Have a history of, in the opinion of the investigator, excessive methylxanthine use
within the previous 6 months, or are unwilling to abide by restrictions as specified
in Section 6.3.2. Excessive intake is defined as more than 6 units of caffeine per
day; one caffeine unit is contained in the following items: 1 (177 mL) cup of coffee,
1 (355 mL) cup of tea, 2 (355 mL) cans of cola, or 3 oz (85 g) of chocolate
26. Involvement in the planning and/or conduct of the study (applies to Abbisko staff, CRO
staff, and staff at the study site)
27. in the opinion of the investigator or sponsor, are unsuitable for inclusion in the
study
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