Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614608
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASKC200
Brief 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 lt 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
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 lt 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None