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

Phase 1 Completed 50 enrolled Yunnan Zhongke Longjin Biotechnology Co.,Ltd.

RandomizedParallel-groupDouble-blindOther

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

Timeline

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ZKLJ02	Unknown	10 mg	Intravenous
Subject	ZKLJ02	Unknown	20 mg	Intravenous
Subject	ZKLJ02	Unknown	40 mg	Intravenous
Subject	ZKLJ02	Unknown	80 mg	Intravenous
Subject	ZKLJ02	Unknown	120 mg	Intravenous

Indications

No indication recorded.