A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects
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 32 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.
⁃ Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
• 1\. Healthy, adult, male or female (of non-childbearing potential only)\*, 18 55 years of age, inclusive, at the screening visit.
⁃ Females of non-childbearing potential are defined as follows:
∙ Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
∙ o Hysteroscopic sterilization
∙ o Bilateral tubal ligation or bilateral salpingectomy
∙ o Hysterectomy
• 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.
∙ 4\. Body mass index (BMI) ≥ 18.0 and \< 32.0 kg/m2 at the screening visit. 5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:
‣ Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg
‣ Liver function tests at or below limit or normal range
‣ Estimated glomerular filtration rate (estimated by Modification of Diet in Renal Disease Study equation \[MDRD\] method) ≥ 90 mL/min/1.73 m² 6. No ECG findings of clinical significance as judged by the PI or qualified designee at the screening visit and at first check in, including each criterion as listed below:
‣ Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive)
‣ QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females)
‣ QRS interval \< 110 msec; if \> 110 msec, result will be confirmed by a manual over read
‣ PR interval ≤ 210 msec 7. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.