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Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd
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
Conditions
Interventions
JKN2501
Administration: Intravenous (IV) infusion.
Placebo
0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion.
Locations (1)
The Third hospital of Changsha
Changsha, Hunan, China