NCT07710560

Brief 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 pharmacodynamics of KL0011034 injection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at P25-P50 for phase_1 chronic-pain

Timeline
Completed

Started Jul 2026

Shorter than P25 for phase_1 chronic-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

16 days

First QC Date

July 5, 2026

Last Update Submit

July 13, 2026

Conditions

Chronic Pain

Keywords

chronic pain

Outcome Measures

Primary Outcomes (1)

  • Number of reported Adverse Events

    Safety and tolerability was assessed by the number of volunteers with adverse events.

    24 hours post-dose for each period

Secondary Outcomes (9)

  • PK parameter Cmax in plasma

    24 hours post-dose for each period

  • PK parameter Tmax in plasma

    24 hours post-dose for each period

  • PK parameter AUC0-t in plasma

    24 hours post-dose for each period

  • PK parameter AUC0-∞ in plasma

    24 hours post-dose for each period

  • PK parameter t1/2 in plasma

    24 hours post-dose for each period

  • +4 more secondary outcomes

Study Arms (3)

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

Drug: KL0011034 injectionDrug: 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;

Drug: KL0011034 injectionDrug: 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;

Drug: KL0011034 injectionDrug: Alfentanil Hydrochloride Injection

Interventions

KL0011034 injectionDRUG

Intravenous injection, single dose

Sequence ASequence BSequence C
Alfentanil Hydrochloride InjectionDRUG

Intravenous injection, single dose

Sequence ASequence BSequence C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third XIANGYA Hospital of Central South University

Changsha, Hunan, 410205, China

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Alfentanil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Wei Qi

CONTACT

028-82339360qiw@kelun.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 17, 2026

Study Start

July 15, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)