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RECRUITING
NCT07207291
PHASE1

Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd

View on ClinicalTrials.gov

Summary

This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts: Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis. Part 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults. Dose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-08-22

Completion Date

2026-03-19

Last Updated

2025-10-03

Healthy Volunteers

Yes

Interventions

DRUG

JKN2501

Administration: Intravenous (IV) infusion.

DRUG

Placebo

0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion.

Locations (1)

The Third hospital of Changsha

Changsha, Hunan, China