NCT07412938

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

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single Oral Doses of JKN2306 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study consisted of a single ascending dose (SAD) part and a food effect (FE) part. The SAD part was a single-center, randomized, double-blind, placebo-controlled study with five dose cohorts (10 mg, 30 mg, 100 mg, 200 mg, and 400 mg). The FE assessment was conducted sequentially in subjects participating in the 200 mg cohort using two dosing periods separated by a washout; dosing was performed under fasting conditions in Period 1 and under fed conditions (high-fat, high-calorie meal) in Period 2. Pharmacokinetic sampling and safety assessments were performed per protocol, and exploratory assessments included concentration-QTc analysis and metabolite profiling.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	JKN2306	JKN2306 tablet, oral
DRUG	Placebo	matching placebo tablet

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-07-02
• Completion: 2025-07-02
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China