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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
Sponsor: Yunnan Zhongke Longjin Biotechnology Co.,Ltd.
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
Conditions
Interventions
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.
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.
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.
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.
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