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A Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection in Participants With Moderate-to-Severe Non-Cancer Chronic Pain

NCT07751094 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-08-07

No results posted yet for this study

Summary

This study will evaluate the drug-drug interaction between KL0011034 Injection and Alfentanil Hydrochloride Injection in participants with moderate-to-severe non-cancer chronic pain. The study consists of two parts. Part 1 is a single-center, randomized, open-label, parallel-design study to evaluate the safety, tolerability, and pharmacodynamics of the combination. Approximately 9 participants will be enrolled and randomized to one of three dose groups (n=3 per group). Part 2 is a single-center, randomized, open-label, three-sequence, three-period crossover study to evaluate the pharmacokinetic interaction, safety, tolerability, and pharmacodynamic effects. Approximately 18 participants will be enrolled and randomized to one of three sequences (n=6 per sequence), with a 3-day washout period between each period.

Conditions

Interventions

DRUG

KL0011034 injection

KL0011034 Injection is an investigational drug being studied for its analgesic properties in combination with alfentanil. It is administered via intravenous infusion. The dose levels evaluated are 0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg in Part 1; the selected dose from Part 1 is used in Part 2.

DRUG

Alfentanil Hydrochloride Injection

Alfentanil Hydrochloride Injection is an opioid analgesic administered via intravenous bolus at a fixed dose of 5 μg/kg. It is used alone and in combination with KL0011034 Injection to evaluate drug-drug interaction.

Sponsors & Collaborators

  • Hunan Kelun Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Kelun Pharmaceutical Co.,Ltd.

    collaborator INDUSTRY

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2027-07-31
Completion
2027-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751094 on ClinicalTrials.gov