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COMPLETED
NCT07638098
PHASE1

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

Sponsor: Yunnan Zhongke Longjin Biotechnology Co.,Ltd.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-11

Completion Date

2025-11-18

Last Updated

2026-06-10

Healthy Volunteers

Yes

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.

Locations (1)

Yunnan Zhongke Longjin Biotechnology Co.,Ltd.

Kunming, Yunnan, China