A Phase Ia Study of KMY Tablets in Healthy Subjects | NCT07314541

NCT07314541

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KMY Tablets	Experimental	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 Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KMY Tablets	Drug	KMY Tablets is an investigational drug product. This study evaluates its safety, tolerability, and pharmacokinetics in healthy subjects.	KMY Tablets

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female participants aged 18 to 45 years (inclusive).
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).
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.
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：

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).
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.
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.
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.
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.
History of drug abuse or positive urine drug screen.
Donation or loss of ≥400 mL of blood, or receipt of blood products, within a specified period (e.g., 6 months) prior to screening.
History of alcohol abuse, inability to abstain from alcohol during the study, or positive alcohol breath test.
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.
Intolerance to venipuncture or history of needle or blood phobia.
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:
Pregnant or lactating women, or women with a positive pregnancy test.
Unwilling to use effective contraception during the study and for a specified period thereafter.