Healthy VolunteersPhase 1NCT07314541
A Phase Ia Study of KMY Tablets in Healthy Subjects
A Phase 1 study testing KMY Tablets in people with Healthy Volunteers, run by Lei Yunshang Group at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- KMY Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 7 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Yanxia YU, PhD, +86-150-5140-4960, yuyxsz@163.com
About this study
Official title: 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:
Read more
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.
Read the 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
- Being tested
- KMY Tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KMY TabletsDrug
Also called Investigational Product
KMY Tablets is an investigational drug product. This study evaluates its safety, tolerability, and pharmacokinetics in healthy subjects.
PlaceboDrug
Also called Placebo matching KMY Tablets
A placebo tablet matching the appearance of the active KMY Tablets. It contains no active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Pre-dose, and at multiple timepoints up to 72 hours post-dose in each study period (Period 1 and Period 2).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Urine/feces collection at intervals from 0 to 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start15 Dec 2025
- Primary completion7 Nov 2026 (estimated)
- Study completion7 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Yunshang Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanxia Yu, PhD, Principal investigator, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314541
- Sponsor's protocol ID
- 2025-CP-KMY-01
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of KMY Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07314541
- Acronym / sponsor ID
- 2025-CP-KMY-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lei Yunshang GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 7 Nov 2026 (estimated)
- Study completion
- 7 Nov 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KMY Tablets | Experimental | Drug: KMY TabletsParticipants 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. |
| KMY Tablets Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KMY TabletsAlso: Investigational ProductKMY Tablets is an investigational drug product. This study evaluates its safety, tolerability, and pharmacokinetics in healthy subjects. | Drug | KMY Tablets |
| PlaceboAlso: Placebo matching KMY TabletsA placebo tablet matching the appearance of the active KMY Tablets. It contains no active pharmaceutical ingredient. | Drug | KMY Tablets Placebo |
Primary outcome
Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to 7 days after the last dose (assessed up to approximately 4 weeks).
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)
Food Effect: Maximum Observed Plasma Concentration (Cmax) of KMY Tablets
Time frame: Pre-dose, and at multiple timepoints up to 72 hours post-dose in each study period (Period 1 and Period 2).
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.
3 secondary outcomes
Area Under the Plasma Concentration-Time Curve (AUC) of KMY Tablets
Time frame: Pre-dose, and at multiple timepoints up to 72 hours post-dose.
Time to Maximum Plasma Concentration (Tmax) of KMY Tablets
Time frame: Pre-dose, and at multiple timepoints up to 72 hours post-dose.
Cumulative Excretion of KMY and its Metabolites
Time frame: Urine/feces collection at intervals from 0 to 72 hours post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanxia Yu, PhD principal investigator
Suzhou Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KMY Tablets in people with Healthy Volunteers, run by Lei Yunshang Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanfen Wang (+86-18662172332, wangyanfen@lys.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to 7 days after the last dose (assessed up to approximately 4 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.