PRG Science & Technology Co., Ltd.
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.
During this trial, a total of 48 subjects will be randomized in a 3:1 ratio (out of 8 subjects, 6 on Amisodin, 2 on placebo in each dose group). The placebo is a capsule that looks like Amisodin but contains no study drug. The use of a placebo helps to make sure that any side effects during the study are judged fairly. In Part 1 (SAD), subjects will receive a single oral dose of Amisodin or placebo under fasting conditions, with one cohort crossing over to receive the same treatment under fed conditions to assess the effect of food. In Part 2 (MAD), subjects will receive Amisodin or placebo o…
Inclusion Criteria: 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 oophore…
Administered as specified in the treatment arm.
Administered as specified in the Placebo arm.
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