A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.
WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;
Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH > 40 mIU/mL can confirm menopause.
1. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.
Sequential
BDHK-2009 Tablets
DrugAdministration: Oral
Placebo
DrugAdministration: Oral
To evaluate the safety and tolerability of a single dose/multiple doses of BDHK-2009 in healthy participants.
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0 including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, and physical examination
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Peak plasma Concentration (Cmax)
To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.
Area under the drug concentration-time curve (AUC)
To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.
Time to maximum observed concentration (Tmax)
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Terminal half-life (t½)
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