| Eligibility |
Inclusion Criteria:
1. Participants must be able to understand the nature of the trial and provide a signed
and dated, written informed consent form before any study-specific procedures,
sampling, and analyses.
2. Female and/or male aged 18~55 years (inclusive), at the time of signing the informed
consent.
3. Body mass index (BMI) 18~30 kg/m2. Bodyweight of = 45 kg (Female) or = 55 kg (Male).
4. Non-smoker (never smoked or > 1 year from the last occurrence of smoking).
5. Participants are healthy as determined by medical history, physical examination,
laboratory parameters, vital signs and ECG, performed before the first administration
of the study drug, including the following criteria:
- Normal AST, ALT, total bilirubin and serum alkaline phosphatase
- Normal white blood cell (WBC), hemoglobin and platelet count
- Normal coagulation function
- CrCl = 90 mL/min or eGFR > 80 mL/min/1.73m^2
- QT/QTc interval < 450 ms
6. Male participants must be surgically sterile or using an acceptable method of
contraception (defined as barrier methods in conjunction with spermicides) during the
study (from the time they sign consent) and for 6 months after the last dose of the
study drug to prevent pregnancy with a partner. Abstinence is an acceptable form of
contraception, provided that the subject agrees to use barrier methods in conjunction
with spermicides if they do engage in sexual intercourse.
However, periodic abstinence, the rhythm method, and the withdrawal method are not
acceptable methods of contraception. Male participants should refrain from sperm
donation throughout this period.
Female partners (of childbearing potential) of male participants must also use a
highly effective method of contraception throughout this period.
7. Female participants must have negative pregnancy tests at screening and check-in AND:
have been surgically sterile (with documentation of hysterectomy, bilateral
oophorectomy, bilateral salpingectomy, bilateral tubal ligation/tubal occlusion) OR
post-menopausal (no menstruation for a minimum of 12 months and confirmed by
follicle-stimulating hormone (FSH) and serum estradiol at screening) OR, if of
child-bearing potential, 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, oral, patch or vaginal hormonal
contraceptive, condom, spermicide, or sponge) for the last three months. All females
must agree to continue to use their method of birth control for the duration of the
study and a minimum of one complete menstrual cycle.
Exclusion Criteria:
1. Any condition which in the opinion of the investigator would interfere with the
participant's ability to provide informed consent, comply with study instructions,
confound interpretation of study results, or endanger the participant if he or she
takes part in the trial.
2. Any of the following condition: positive Hepatitis B surface antigen (HBsAg), positive
HCV antibodies, confirmed positive HIV test result, TB test or COVID-19 test.
3. History of malignancy of any type, except the following: surgically excised
non-melanomatous skin cancers more than 5 years before receiving the study drug.
4. Has donated blood (including blood products) or experienced loss of blood = 500 mL
within 2 months before screening.
5. Reported history or any clinically significant abnormalities at the screening of
cardiac, hepatic, renal, respiratory, GI, endocrine, immunological, dermatological,
hematological, neurological, or psychiatrical disease.
6. Resting blood pressure > 140/90 mmHg at screening (a single repeat measurement is
allowed if the initial measurement is outside of these limits). Resting pulse rate <
45 beats per minute.
7. Ingestion of grapefruit, grapefruit juice, pomegranate juice, star fruit, or orange
marmalade (made with Seville oranges) within 1 week before screening.
8. Participation in another clinical study with an investigational product administered
in the last 28 days.
9. Have previously completed or withdrawn from this study or any other study
investigating DZD8586 and have previously received DZD8586.
10. Involvement in the planning and/or conduct of the study (applies to both Dizal staff
and/or staff at the study site).
11. Previous enrolment or randomization in the present study.
12. For women only - currently pregnant (confirmed with positive pregnancy test) or
breast-feeding.
13. Testing positive for alcohol and/or drugs of abuse at screening and check-in.
14. Self-reported substance abuse (e.g., alcohol, licit or illicit drugs) within 12 months
of screening.
15. Unwilling or unable to limit the substance such as alcohol consumption as defined in
the restriction section throughout the course of the study.
16. Received a live or live-attenuated vaccine within 3 months before the first dose of
the study drug, except COVID-19 vaccine (within 2 weeks).
17. Use or intend to use any prescription within 28 days prior to study drug
administration, unless deemed acceptable by the investigator (or designee).
Concomitant prescription drugs should also be restricted during administration of
study drug. Exceptions may be allowed on a case-by-case basis as agreed by the
investigator and sponsor's medical monitor if considered not to interfere with the
aims of the study.
18. Use or intend to use any nonprescription medications/products including vitamins,
minerals, and phytotherapeutic/herbal/plant derived preparations, gastric pH
modifiers, and neutralizing antacids within 14 days prior to study drug
administration, unless deemed acceptable by the investigator (or designee).
Concomitant non-prescription drugs should also be restricted during administration of
study drug.
19. Use or intend to use slow-release medications/products considered to still be active
within 14 days prior to check-in, unless deemed acceptable by the investigator (or
designee).
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