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New painkiller combo under study: could it improve chronic pain treatment?

NCT ID NCT07710560

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This trial investigates how a new experimental drug called KL0011034 interacts with alfentanil, a strong opioid painkiller, in adults with moderate-to-severe chronic pain. The study measures how the drugs affect each other's levels in the body and monitors safety. Participants receive single doses of each drug alone and together to compare the effects.

What this could mean

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

Active substance
KL0011034 injection and alfentanil hydrochloride injection
What this could lead to
If successful, this study could help determine safe dosing when combining KL0011034 with alfentanil for chronic pain management.
What could go wrong
This is an early-phase trial with only 27 participants, so results may not apply broadly. Drug interactions could cause unexpected side effects.

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

27 people

The number who actually took part.

Started

Jul 2026

Finished

Aug 2026

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. patients with moderate-to-severe non-cancerous chronic pain (Age: 18\~55 years, NRS score≥4); 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, chest x-ray, abdominal B-ultrasound, laboratory tests; 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 inducers or inhibitors of CYP3A4 or CYP2C19 enzymes within 30 days; 10. History of any clinical study within 3 months; 11. History of any vaccine within 1 month; 12. History of any drug abuse; 13. Needle sickness, Hematosickness; 14. Massive blood loss (\> 400 mL) in the past 3 months; 15. Female volunteers are pregnant or lactating; 16. History of unprotected sex within 2 weeks; 17. Heavy smoker ( more than 5 cigarettes/day) within 3 months; 18. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months; 19. Heavy caffeine intake; 20. History of grapefruit, xanthine-rich foods intake within 48 hours; 21. Positive alcohol test; 22. Positive nicotine test; 23. Positive drugs of abuse test result.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome

As listed by the trial registrant

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

Chronic pain

Contacts and locations

Locations

  • The Third XIANGYA Hospital of Central South University

    Changsha, Hunan, 410205, China

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