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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: KMY Tablets; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanfen Wang; Phone Number: +86-18662172332; Email: wangyanfen@lys.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Suzhou Municipal Hospital
      • Contact: Yanxia YU, PhD; Phone Number: +86-150-5140-4960; Email: yuyxsz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female participants aged 18 to 45 years (inclusive).
2. Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body Mass Index (BMI) is between 19.0 and 26.0 kg/m² (inclusive).
3. Participants agree to use effective contraception from screening until a specified period after the last dose and have no plan for pregnancy, sperm donation, or egg donation.
4. Voluntarily participate in the trial, fully understand the study, sign the informed consent form, and are able to comply with the study procedures.

Exclusion Criteria：

1. Known history of allergy to the active ingredient, excipients of the investigational drug, or related compounds; or allergic constitution (e.g., allergy to two or more drugs or foods).
2. History or presence of severe chronic diseases of the cardiovascular, hepatic, renal, respiratory, hematological, endocrine, immune, psychiatric, or neurological systems within the past year, which in the investigator's judgment may compromise participant safety or study integrity.
3. Abnormal and clinically significant findings in vital signs, physical examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation), or 12-lead ECG at screening, as judged by the investigator.
4. Use of any medications (including prescription, over-the-counter, or herbal medicines) or health supplements within a specified period (e.g., 2 weeks) prior to screening.
5. Participation in another clinical trial (drug or medical device) or use of any other investigational drug within a specified period (e.g., 3 months) prior to screening.
6. History of drug abuse or positive urine drug screen.
7. Donation or loss of ≥400 mL of blood, or receipt of blood products, within a specified period (e.g., 6 months) prior to screening.
8. History of alcohol abuse, inability to abstain from alcohol during the study, or positive alcohol breath test.
9. Smoking more than a specified number of cigarettes per day (e.g., 5) within a specified period prior to screening, or inability to cease use of tobacco products during the study.
10. Intolerance to venipuncture or history of needle or blood phobia.

11. Any other condition that, in the investigator's opinion, may pose a risk to the participant or interfere with the evaluation of study results.

    Additional Exclusion Criteria for Female Participants:

12. Pregnant or lactating women, or women with a positive pregnancy test.
13. Unwilling to use effective contraception during the study and for a specified period thereafter.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KMY Tablets; Participants will receive the active drug, KMY tablet. The study consists of three parts: Part A (Single Ascending Dose): Participants will be assigned to one of eight predefined dose cohorts (2, 6, 10, 20, 40, 60, 90, or 120 mg) to receive a single dose of KMY tablet or matching placebo under fasting conditions. Part B (Multiple Ascending Dose): Participants will be assigned to one of three predefined dose regimens (40 mg QD, 80 mg QD, or 40 mg BID) to receive KMY tablet or matching placebo for 7 consecutive days under fasting conditions. Part C (Food Effect): All participants will receive a single dose of 60 mg KMY tablet in a two-period, two-sequence crossover design, once under fasting conditions and once after a high-fat, high-calorie meal. This arm includes all participants who receive the active KMY tablet, regardless of the study part, dose level, or fed/fasting condition.	Drug: KMY Tablets; KMY Tablets is an investigational drug product. This study evaluates its safety, tolerability, and pharmacokinetics in healthy subjects.; Other Names: Investigational Product
Placebo Comparator: KMY Tablets Placebo; Participants will receive a placebo tablet identical in appearance to the KMY tablet but containing no active ingredient. The placebo is used only in the randomized, double-blind, controlled portions of the study (Part A and Part B). Within each dose cohort of Part A and Part B, a subset of participants will be randomized to this arm. This arm does NOT include participants from the open-label Part C study.	Drug: Placebo; A placebo tablet matching the appearance of the active KMY Tablets. It contains no active pharmaceutical ingredient.; Other Names: Placebo matching KMY Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events (TEAEs)	The number and percentage of participants with all-cause adverse events (AEs), including serious adverse events (SAEs) and AEs leading to study drug discontinuation. Severity will be graded according to NCI CTCAE v5.0. (Note: Specify the exact grading scale you use, e.g., NCI CTCAE v5.0)	From first dose of study drug up to 7 days after the last dose (assessed up to approximately 4 weeks).
Food Effect: Maximum Observed Plasma Concentration (Cmax) of KMY Tablets	The maximum observed plasma concentration (Cmax) of KMY Tablets following a single oral dose under fed (high-fat, high-calorie meal) conditions compared to fasting conditions.	Pre-dose, and at multiple timepoints up to 72 hours post-dose in each study period (Period 1 and Period 2).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration-Time Curve (AUC) of KMY Tablets	The area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) and extrapolated to infinity (AUC0-∞) following single and multiple doses of KMY Tablets.	Pre-dose, and at multiple timepoints up to 72 hours post-dose.
Time to Maximum Plasma Concentration (Tmax) of KMY Tablets	The time to reach the maximum observed plasma concentration (Cmax) following single and multiple doses of KMY Tablets.	Pre-dose, and at multiple timepoints up to 72 hours post-dose.
Cumulative Excretion of KMY and its Metabolites	The cumulative amount of KMY and its major metabolites excreted in urine and feces (if collected) over a specified time period.	Urine/feces collection at intervals from 0 to 72 hours post-dose.

Collaborators and Investigators

• Sponsor: Lei Yunshang Group
• Investigators: Principal Investigator: Yanxia Yu, PhD, Suzhou Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): November 7, 2026
• Study Completion (Estimated): November 7, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-CP-KMY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No