NCT06614608

The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain

A Multi-Center, Randomized, Double-blind Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASKC200 in Patients with Osteoarthritic Knee Pain

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKC200 in subjects with OA of the knees and determine the phase II recommended dose. Assigned doses will be applied for 60 minutes on each of four consecutive days.

Detailed description

Subjects will be randomized to one of the two Arms in this study: 5% ASKC200 or 1% ASKC200. All subjects will receive 4 consecutive days of treatment and will then be followed up until the Day 34 visit. The NRS score of weekly average of average daily pain intensity (WAADPI) of the study knee should ≥ 5 and the NRS score of WAADPI of the contralateral knee should \< 4 at screening. Data will be collected from Day 1 through Day 5 and then again on Days 19 and 34 for efficacy, tolerability, and safety measures.

Conditions

• Osteoarthritis, Knee
• Pain

Interventions

Type	Name	Description
DRUG	5% ASKC200	5% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.
DRUG	1% ASKC200	1% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of1% for this study.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2024-09-26
• Last updated: 2024-09-27

Locations

1 site across 1 country: China