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Healthy volunteers needed to test safety of experimental drug KLA478

NCT ID NCT07240675

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests whether a single dose of KLA478 is safe and how the body processes it. About 40 healthy adults aged 18-45 will receive the drug and be monitored for side effects and drug levels in the blood. No treatment benefit is expected; the goal is to gather safety information before testing in patients.

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 40 people

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

Started

Nov 2025

Expected to finish

Sep 2026

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 45 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. Sign the informed consent form 2. Health participants (Age: 18\~45 years); 3. Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 28.0kg/m2; 4. Clinical examination normal, or abnormal with no clinical significance; 5. Agreed to use contraception for 3-6 months. Exclusion Criteria: 1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia; 4. Assess injection site abnormalities; 5. History of drugs that may interact with pramipexole within 1 month; 6. History of any Medication within 2 weeks; 7. Massive blood loss (\> 200 mL) in the past 3 months; 8. History of any surgery within 3 months, or plan to undergo surgery during the trial; 9. History of any clinical study within 90 days; 10. History of any vaccine within 1 month,or Plan to get vaccinated during the trial period; 11. systolic blood pressure decreased ≥20 mmHg or diastolic blood pressure decreased ≥10 mmHg within 3 minutes from supine to upright position; 12. QTcF\>450 ms; 13. Abnormal vital signs with clinical significance ; 14. Serum potassium level exceeds the reference range.; 15. Pre-transfusion test abnormal; 16. Lactation or pregnancy test positive ; 17. History of any drug abuse or positive drugs of abuse test result; 18. Previous alcohol abuse or unwillingness to stop drinking or alcohol breath test positive; 19. more than 3 cigarettes per day in 3 months, or unwilling to stop during the trial; 20. Intake of special diets that affect drug absorption, distribution, metabolism and excretion within 48 hours; 21. Have special requirements for diet; 22. Unprotected sexual behavior within 2 weeks; 23. engaged in driving vehicles, operating machinery, high-altitude work or other potentially dangerous behavior; 24. Inappropriate for participation in this trial as judged by the investigator.

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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

  • Huashan Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201107, China

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