JKN2306 in Healthy Subjects: Single Ascending Dose and Food Effect Study

Phase 1 Completed 44 enrolled Joincare Pharmaceutical Group Industry Co., Ltd

RandomizedParallel-groupTriple-blindTreatment

Summary

This first-in-human, single-center study in China evaluated the safety, tolerability, and pharmacokinetics of single oral doses of JKN2306 tablets in healthy adult subjects and assessed the effect of a high-fat, high-calorie meal on the pharmacokinetics of JKN2306.

Timeline

Start: 2025-02-12
Primary completion: 2025-07-02
Completion: 2025-07-02

Publications

Yang Y, Han M, Cui G, Zhang D, Wu W, Mi N, Jin J, Zhang S, Zhang X, Li J, Xiao C, Wang J, Gou C, Su C, Li J. A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Highly Selective NaV1.8 Inhibitor JKN2306 in Healthy Chinese Subjects. Pharmacol Res Perspect. 2026 Jun;14(3):e70277. doi: 10.1002/prp2.70277.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JKN2306	Unknown	10 mg	Oral
Subject	JKN2306	Unknown	30 mg	Oral
Subject	JKN2306	Unknown	100 mg	Oral
Subject	JKN2306	Unknown	200 mg	Oral
Subject	JKN2306	Unknown	400 mg	Oral

Indications

No indication recorded.