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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZKLJ02 Injection in Healthy Chinese Research Participants

NCT07638098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-10

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous administration of ZKLJ02 injection in healthy Chinese research participants

Conditions

  • Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants

Interventions

DRUG

10 mg of ZKLJ02 for injection or placebo

Dissolve 10 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.

DRUG

20 mg of ZKLJ02 for injection or placebo

Dissolve 20 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.

DRUG

40 mg of ZKLJ02 for injection or placebo

Dissolve 40 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.

DRUG

80 mg of ZKLJ02 for injection or placebo

Dissolve 80 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.

DRUG

120 mg of ZKLJ02 for injection or placebo

Dissolve 120 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.

Sponsors & Collaborators

  • Yunnan Zhongke Longjin Biotechnology Co.,Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2025-11-18
Completion
2025-11-18

Countries

  • China

Study Locations

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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 NCT07638098 on ClinicalTrials.gov