Chronic PainPhase 1NCT07710560

A Study Evaluating the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection

A Phase 1 study testing KL0011034 injection and Alfentanil Hydrochloride Injection in people with Chronic Pain, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the pharmacokinetic interaction of KL0011034 injection in combination with alfentanil hydrochloride injection.To evaluate the safety and tolerability of KL0011034 injection in combination with alfentanil hydrochloride injection.To evaluate the effect of alfentanil hydrochloride injection on the… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Chronic Pain
What is being tested?: KL0011034 injection and Alfentanil Hydrochloride Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteChina
Study dates: 15 Jul 2026to 12 Aug 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

patients with moderate-to-severe non-cancerous chronic pain (Age: 18~55 years, NRS score≥4);
Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;

Who cannot join

Allergy or Drug hypersensitivity;
Clinically significant Medical History;
History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;

Show all 23Show fewer

History of any surgery within 3 months;
History of any Medication within 14 days;
History of any inducers or inhibitors of CYP3A4 or CYP2C19 enzymes within 30 days;
History of any clinical study within 3 months;
History of any vaccine within 1 month;
History of any drug abuse;
Needle sickness, Hematosickness;
Massive blood loss (> 400 mL) in the past 3 months;
Female volunteers are pregnant or lactating;
History of unprotected sex within 2 weeks;
Heavy smoker ( more than 5 cigarettes/day) within 3 months;
History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
Heavy caffeine intake;
History of grapefruit, xanthine-rich foods intake within 48 hours;
Positive alcohol test;
Positive nicotine test;
Positive drugs of abuse test result.

Trial locations and contacts

1 site in 1 country.

China1 site

The Third XIANGYA Hospital of Central South University
Changsha, Hunan, 410205

Other trials in China

About this study

Official title: A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period Crossover Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection

Read the detailed description

This study will be conducted among the participants with moderate-to-severe non-cancerous chronic pain, aiming to evaluate the drug-drug interactions between KL0011034 injection and alfentanil hydrochloride injection. The study consists of two parts:

Part 1 trial:

A single-center, randomized, open, parallel design is adopted to evaluate the safety, tolerability and pharmacodynamic characteristics of the combined use of KL0011034 injection and alfentanil hydrochloride injection.

It is planned to enroll 9 patients with moderate-to-severe non-cancerous chronic pain. All participants will be randomly assigned to one of the three dose groups in a 1:1:1 ratio, with 3 participants in each group. They will complete a single combined administration and undergo pharmacodynamic and safety evaluations.

Based on the results of Part 1 trial, KL0011034 injection will select the maximum dose with acceptable safety among the three doses for the second part of the study.

Part 2 trial:

A single-center, randomized, open, three-sequence, three-period crossover trial design is adopted to evaluate the PK interactions, safety and tolerability of the combined use of KL0011034 injection and alfentanil hydrochloride injection, as well as the effect of alfentanil hydrochloride injection on the pharmacodynamics of KL0011034 injection.

It is planned to enroll 18 patients with moderate-to-severe non-cancerous chronic pain. All participants will be randomly assigned to one of the three sequences A, B, and C in a 1:1:1 ratio, with 6 participants in each sequence. They will complete three periods of open administration and undergo PK blood sampling, pharmacodynamic and safety evaluations, with a 3-day washout period for each period.

Conditions: Chronic Pain
Being tested: KL0011034 injection, Alfentanil Hydrochloride Injection
Keywords: chronic pain
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KL0011034 injectionDrug
Intravenous injection, single dose
Alfentanil Hydrochloride InjectionDrug
Intravenous injection, single dose

Study groups in NCT07710560
Study group	Role	What they receive
Sequence A	Experimental	Period 1, 6 participants will receive KL0011034 injection; Period 2, 6 participants will receive Alfentanil Hydrochloride Injection; Period 3, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
Sequence B	Experimental	Period 1, 6 participants will receive Alfentanil Hydrochloride Injection; Period 2, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection; Period 3, 6 participants will receive KL0011034 injection; Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
Sequence C	Experimental	Period 1, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection; Period 2, 6 participants will receive KL0011034 injection; Period 3, 6 participants will receive Alfentanil Hydrochloride Injection; Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of reported Adverse Events
Safety and tolerability was assessed by the number of volunteers with adverse events.
Measured: 24 hours post-dose for each period

Secondary outcomes (9)

PK parameter Cmax in plasma
Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. Cmax of Alfentanil combining with or without KL0011034 injection.
Measured: 24 hours post-dose for each period
PK parameter Tmax in plasma
Time of Cmax (Tmax) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. Tmax of Alfentanil combining with or without KL0011034 injection.
Measured: 24 hours post-dose for each period
PK parameter AUC0-t in plasma
Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. AUC0-t of Alfentanil combining with or without KL0011034 injection.
Measured: 24 hours post-dose for each period
PK parameter AUC0-∞ in plasma
AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. AUC0-∞ of Alfentanil combining with or without KL0011034 injection.
Measured: 24 hours post-dose for each period
PK parameter t1/2 in plasma
Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. t1/2 of Alfentanil combining with or without KL0011034 injection.
Measured: 24 hours post-dose for each period
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
MOAA/S is a commonly used clinical sedation assessment scale, ranging from 0 to 5, which helps clinicians determine the level of sedation in patients. A score of 5 indicates full consciousness, whereas a score of 0 indicates deep coma. Lower scores correspond to deeper levels of sedation.
Measured: Day 1 for each period
Electroencephalogram bispectrality index (BIS) monitoring
BIS is the most widely used method for the continuous monitoring of sedation depth in clinical anesthesia. BIS values range from 0 to 100, where 100 represents complete wakefulness and 0 indicates complete cortical electrical inhibition.
Measured: Day 1 for each period
Loss of eyelash reflex
The eyelash reflex is a commonly used clinical method to assess the level of consciousness in patients. Gentle stimulation of the eyelashes with a cotton swab normally elicits a blink; absence of this response indicates loss of the eyelash reflex.
Measured: Day 1 for each period
Modified Aldrete Scoring (Aldrete) Scale
The Modified Aldrete Score is the most widely used standardized tool for assessing discharge readiness from post-anesthesia care unit (PACU). It evaluates five parameters: activity, respiration, blood pressure consciousness, and SpO₂. Ranging from 0 to 10, the higher the score, the better the quality of recovery.
Measured: Day 1 for each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202612 Aug 2026

First posted17 Jul 2026
Study start15 Jul 2026
Primary completion12 Aug 2026
Study completion12 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07710560
Sponsor's protocol ID: KL0011034-102
Status last verified: Sep 2026
First submitted: 5 Jul 2026
Last updated: 17 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
RecruitingObservational study
Different Treatments in Chronic Pain Patients.
Chronic Pain, Nociplastic Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period Crossover Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection
ClinicalTrials.gov ID: NCT07710560
Acronym / sponsor ID: KL0011034-102
Conditions: Chronic Pain
Keywords: chronic pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Jul 2026 (actual)
Primary completion: 12 Aug 2026 (actual)
Study completion: 12 Aug 2026 (actual)
First posted: 17 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Part 1 trial:

Based on the results of Part 1 trial, KL0011034 injection will select the maximum dose with acceptable safety among the three doses for the second part of the study.

Part 2 trial:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Sequence A	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPeriod 1, 6 participants will receive KL0011034 injection; Period 2, 6 participants will receive Alfentanil Hydrochloride Injection; Period 3, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection
Sequence B	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPeriod 1, 6 participants will receive Alfentanil Hydrochloride Injection; Period 2, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection; Period 3, 6 participants will receive KL0011034 injection;
Sequence C	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPeriod 1, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection; Period 2, 6 participants will receive KL0011034 injection; Period 3, 6 participants will receive Alfentanil Hydrochloride Injection;

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

patients with moderate-to-severe non-cancerous chronic pain (Age: 18~55 years, NRS score≥4);
Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;

Key exclusion criteria (23 listed)

Allergy or Drug hypersensitivity;
Clinically significant Medical History;
History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KL0011034 injectionIntravenous injection, single dose	Drug	Sequence A, Sequence B, Sequence C
Alfentanil Hydrochloride InjectionIntravenous injection, single dose	Drug	Sequence A, Sequence B, Sequence C

Primary outcome

Number of reported Adverse Events
Time frame: 24 hours post-dose for each period
Safety and tolerability was assessed by the number of volunteers with adverse events.

9 secondary outcomes

PK parameter Cmax in plasma
Time frame: 24 hours post-dose for each period
PK parameter Tmax in plasma
Time frame: 24 hours post-dose for each period
PK parameter AUC0-t in plasma
Time frame: 24 hours post-dose for each period
PK parameter AUC0-∞ in plasma
Time frame: 24 hours post-dose for each period
PK parameter t1/2 in plasma
Time frame: 24 hours post-dose for each period
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
Time frame: Day 1 for each period
Electroencephalogram bispectrality index (BIS) monitoring
Time frame: Day 1 for each period
Loss of eyelash reflex
Time frame: Day 1 for each period
Modified Aldrete Scoring (Aldrete) Scale
Time frame: Day 1 for each period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
RecruitingObservational study
Different Treatments in Chronic Pain Patients.
Chronic Pain, Nociplastic Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KL0011034 injection and Alfentanil Hydrochloride Injection in people with Chronic Pain, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of reported Adverse Events (time frame: 24 hours post-dose for each period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07710560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.