Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug KLA578-1 tested in healthy people for first time

NCT ID NCT07143318

Knowledge-focused Sponsor: Hunan Kelun Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new drug called KLA578-1 in 48 healthy volunteers aged 18 to 45. The main goal is to check if the drug is safe and how the body processes it. Participants will receive either a single dose or multiple doses, and researchers will monitor for side effects and measure drug levels in the blood. This study does not aim to treat any disease.

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 48 people

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

Started

Jun 2025

Expected to finish

May 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. Health Volunteers (Age: 18\~45 years); 2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0; 3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests; 4. Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min. Exclusion Criteria: 1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. Gastrointestinal ulcers or gastrointestinal bleeding; 4. History of any surgery within 4 weeks; 5. History of any Medication within 14 days; 6. History of any inducers or inhibitors of major CYP450 enzymes within 30 days; 7. History of any clinical study within 3 months; 8. History of any vaccine within 1 month; 9. History of any drug abuse; 10. Tablet dysphagia; 11. Needle sickness, Hematosickness; 12. Massive blood loss (\> 200 mL) in the past 3 months; 13. Female volunteers are pregnant or lactating; 14. History of unprotected sex within 2 weeks; 15. Special requirements for diet; 16. Heavy smoker ( more than 3 cigarettes/day) within 3 months; 17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months; 18. Heavy caffeine intake; 19. History of grapefruit, xanthine-rich foods intake within 7 days; 20. Positive alcohol test; 21. Positive drugs of abuse test result.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

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 of Central South University

    RECRUITING

    Changsha, Hunan, 611130, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.