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

Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Study ID
NCT07710560
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • KL0011034 injection — DRUG
    Intravenous injection, single dose
  • Alfentanil Hydrochloride Injection — DRUG
    Intravenous injection, single dose

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: Sequence A
    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
  • Experimental: Sequence B
    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;
  • Experimental: Sequence C
    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;

Primary Outcome Measure

Number of reported Adverse Events [ Time Frame: 24 hours post-dose for each period ]

Central Contacts

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