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New drug KR25102 tested in healthy people for first time

NCT ID NCT07618156

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial will test the safety and tolerability of a new drug called KR25102 in 83 healthy adults in China. Participants will receive either a single dose or multiple daily doses of the drug or a placebo. The main goal is to check for side effects and understand how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KR25102

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 83 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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. Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form); 2. Male participants with body weight ≥ 50 kg and female participants with body weight ≥ 45 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m² (inclusive of boundary values); 3. Participants and their partners have no plans for conception, sperm donation or oocyte donation from signing the informed consent form until 2 months after the last dose of study drug, and are willing to adopt highly effective contraceptive measures; 4. Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits; 5. For groups requiring pain testing: willing to undergo pain tests and pass training; with no wounds or skin diseases on the skin at the pain-stimulated site; 6. Participants fully understand the purpose, requirements and potential risks of this trial, are willing to strictly comply with all trial requirements, voluntarily participate in the clinical trial and sign the written informed consent form. Exclusion Criteria: 1. Subjects with previous or current clinical acute or chronic diseases including but not limited to cardiovascular, endocrine-metabolic, neuropsychiatric, digestive, respiratory, hematopoietic-lymphoid, immune, urinary, musculoskeletal diseases and malignant tumors, who are judged unsuitable for enrollment by the investigator; 2. Subjects with personal or family history of hereditary angioedema; 3. Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial; 4. Subjects who have taken any medicines or health supplements (including Chinese herbal medicines) within 14 days before dosing; or those who are known to require other drug treatments during the trial at screening. 5. Subjects who have used any hepatic enzyme inhibitors/inducers within 1 month before dosing (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.). 6. Subjects who have participated in any clinical trials with investigational drugs/devices within 3 months prior to screening, or plan to participate in other clinical trials during the study. 7. Subjects with a history of drug abuse or positive results in drug abuse screening; 8. Subjects with clinically significant abnormal physical examination results at screening or baseline as judged by the investigator; 9. Subjects with positive screening results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody; 10. Subjects with cardiac diseases including but not limited to congenital long QT syndrome, torsades de pointes or risk factors for torsades de pointes (e.g., cardiac insufficiency, family history of long QT syndrome), those currently receiving Class IA anti-arrhythmic drugs (e.g., quinidine or procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone or sotalol) or other drugs known to affect QT interval, or those with Fridericia-corrected QT interval (QTcF) ≥ 450 ms (male), QTcF ≥ 460 ms (female), PR interval \> 200 ms or QRS interval ≥ 120 ms at screening; 11. Subjects who fail pain test training as judged by the investigator (only applicable to groups requiring pain testing).

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Third Xiangya Hospital, Central South University

    Changsha, Hunan, 410006, China

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