Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.
1. Healthy, adult, male or female (of non-childbearing potential only)*, 18 55 years of age, inclusive, at the screening visit.
Bilateral oophorectomy or
Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 Contraception Requirements and agree to refrain from sperm donation until 90 days after the last dosing. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg
1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
Sequential
Amisodin
DrugAdministered as specified in the treatment arm.
Placebo
Other interventionAdministered as specified in the Placebo arm.
Number and severity of TEAEs following a single oral dose of Amisodin and placebo.
To evaluate the safety and tolerability of a single ascending dose of Amisodin in healthy adult subjects.
Pharmacokinetics (PK) of Amisodin
AUC0-t-The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
Pharmacokinetics (PK) of Amisodin
AUC0-inf -The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Pharmacokinetics (PK) of Amisodin
AUC%extrap -Percent of AUC0-inf extrapolated, represented as (1 - AUC-t/AUC-inf) ×100.
Pharmacokinetics (PK) of Amisodin
CL/F - Apparent total plasma clearance after oral (extravascular) administration, calculated as Dose/AUC0-inf.
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