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

Sponsor
The Third Xiangya Hospital of Central South University
Study ID
NCT07751094
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • KL0011034 injection — DRUG
    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.
  • Alfentanil Hydrochloride Injection — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Jul 30, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 1.Alfentanil 5 µg/kg + KL0011034 0.3 mg/kg
    Part 1: Participants receive a single dose of Alfentanil Hydrochloride Injection 5 μg/kg combined with KL0011034 Injection 0.3 mg/kg on Day 1. Safety, tolerability, and pharmacodynamic evaluations are conducted.
  • Experimental: 2.Alfentanil 5 µg/kg + KL0011034 0.35 mg/kg
    Part 1: Participants receive a single dose of Alfentanil Hydrochloride Injection 5 μg/kg combined with KL0011034 Injection 0.35 mg/kg on Day 1. Safety, tolerability, and pharmacodynamic evaluations are conducted.
  • Experimental: 3.Alfentanil 5 µg/kg + KL0011034 0.4 mg/kg
    Part 1: Participants receive a single dose of Alfentanil Hydrochloride Injection 5 μg/kg combined with KL0011034 Injection 0.4 mg/kg on Day 1. Safety, tolerability, and pharmacodynamic evaluations are conducted.
  • Experimental: 4.Sequence A: KL0011034 → Alfentanil → Alfentanil + KL0011034
    Part 2, Sequence A: Participants receive three interventions across three periods (Day 1, Day 4, Day 7) with a 3-day washout between periods: Period 1: KL0011034 Injection (selected dose from Part 1); Period 2: Alfentanil Hydrochloride Injection 5 μg/kg; Period 3: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose from Part 1). Pharmacokinetic, pharmacodynamic, and safety evaluations are conducted.
  • Experimental: 5. Sequence B: Alfentanil → Alfentanil + KL0011034 → KL0011034
    Part 2, Sequence B: Participants receive three interventions across three periods (Day 1, Day 4, Day 7) with a 3-day washout between periods: Period 1: Alfentanil Hydrochloride Injection 5 μg/kg; Period 2: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose from Part 1); Period 3: KL0011034 Injection (selected dose from Part 1). Pharmacokinetic, pharmacodynamic, and safety evaluations are conducted.
  • Experimental: 6. Sequence C: Alfentanil + KL0011034 → KL0011034 → Alfentanil
    Part 2, Sequence C: Participants receive three interventions across three periods (Day 1, Day 4, Day 7) with a 3-day washout between periods: Period 1: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose from Part 1); Period 2: KL0011034 Injection (selected dose from Part 1); Period 3: Alfentanil Hydrochloride Injection 5 μg/kg. Pharmacokinetic, pharmacodynamic, and safety evaluations are conducted.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of KL0011034 [ Time Frame: Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours ]

Central Contacts

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