New drug KMY tablets enter first human safety tests
NCT ID NCT07314541
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This early-phase trial will test the safety and tolerability of KMY tablets in 120 healthy adults aged 18 to 45. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and how the drug moves through the body. The study also looks at how food affects drug absorption. Since this is a first-in-human trial, there is no direct treatment benefit for volunteers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KMY Tablets
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Suzhou Municipal Hospital
RECRUITINGSuzhou, Jiangsu, 215000, China
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