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New sedative candidate goes Head-to-Head with propofol in early human test

NCT ID NCT07828470

Symptom relief Sponsor: Hunan Kelun Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing an experimental intravenous sedative called KL0011034 in healthy Chinese adults aged 18 to 45. The trial compares continuous infusions of KL0011034 with propofol, a standard sedative, over 1, 2, and 3 hours. Participants are randomly assigned and neither they nor the study team know which drug they receive. The main goal is to track side effects and measure how the body processes KL0011034.

What this could mean

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

Active substance
KL0011034, an experimental intravenous sedative
What this could lead to
If it works, KL0011034 could offer another option for keeping patients sedated during procedures, with a safety and dosing profile that doctors can compare to propofol.
What could go wrong
This is a first-in-human style Phase 1 trial in 30 healthy volunteers, so it can only show early safety and how the body handles the drug. It cannot prove the drug works better than propofol, and unknown side effects may appear.

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 30 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 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≤ 26.0kg/m2; 4. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests; 5. Agreed to use contraception for 3 months post-dose. Exclusion Criteria: 1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia; 4. Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation; 5. History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome; 6. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria; 7. History of any surgery within 3 months; 8. History of any Medication within 14 days; 9. History of any clinical study within 3 months; 10. History of any vaccine within 1 month; 11. History of any drug abuse; 12. Needle sickness, Hematosickness; 13. Massive blood loss (\> 400 mL) in the past 3 months; 14. Female volunteers are pregnant or lactating; 15. History of unprotected sex within 2 weeks; 16. Heavy smoker ( more than 5 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 48 hours; 20. Positive alcohol test; 21. Positive nicotine test; 22. Positive drugs of abuse test result.

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As listed by the trial registrant

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

Healthy volunteers

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • The Third XIANGYA Hospital of Central South University

    Changsha, Hunan, 410205, China

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