A Phase Ia Study of KMY Tablets in Healthy Subjects
Sponsor: Lei Yunshang Group • ClinicalTrials.gov ID: NCT07314541
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This is a Phase Ia, randomized, double-blind, placebo-controlled study conducted in healthy subjects. The study plans to enroll a total of 120 participants, with both males and females included in all parts. The trial consists of three distinct parts: Part A (Single-Ascending Dose, SAD): A total of 72 subjects will be enrolled to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of KMY Tablets. Part B (Multiple-Ascending Dose, MAD): A total of 36 subjects will be enrolled to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of KMY Tablets. Part C (Food-Effect): A total of 12 subjects will be enrolled to assess the impact of a high-fat, high-calorie meal on the pharmacokinetic profile of KMY Tablets. The primary objectives are to evaluate the safety and tolerability of single and multiple doses of KMY Tablets and to assess the food effect on its pharmacokinetics. The secondary objectives include characterizing the single- and multiple-dose pharmacokinetics, investigating the drug's metabolism and excretion, and evaluating the safety and tolerability in the fed state. Exploratory pharmacodynamic parameters may also be investigated.
Interventions
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KMY Tablets
(Drug)
KMY Tablets is an investigational drug product. This study evaluates its safety, tolerability, and pharmacokinetics in healthy subjects.
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Placebo
(Drug)
A placebo tablet matching the appearance of the active KMY Tablets. It contains no active pharmaceutical ingredient.
Eligibility criteria
Conditions
Locations
- Suzhou Municipal Hospital — Suzhou, Jiangsu, China
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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