NCT07314541

A Phase Ia Study of KMY Tablets in Healthy Subjects

A Phase Ia, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of KMY Tablets in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Lei Yunshang Group · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a single-center, Phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of KMY Tablets in healthy subjects. The study consists of three parts: a Single-Ascending Dose part, a Multiple-Ascending Dose part, and a Food-Effect part. A total of 120 subjects will be enrolled. The primary objectives are to assess the safety and tolerability profile and to investigate the effect of food on pharmacokinetics. Secondary objectives include characterizing the single- and multiple-dose pharmacokinetic profiles and investigating the metabolism and excretion of KMY Tablets

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	KMY Tablets	KMY Tablets is an investigational drug product. This study evaluates its safety, tolerability, and pharmacokinetics in healthy subjects.
DRUG	Placebo	A placebo tablet matching the appearance of the active KMY Tablets. It contains no active pharmaceutical ingredient.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-11-07
• Completion: 2026-11-07
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China