Status:
ACTIVE_NOT_RECRUITING
Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L
Lead Sponsor:
Anterogen Co., Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
19-70 years
Phase:
PHASE1
Brief Summary
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.
Detailed Description
Study Design: open-label, single-center, dose-escalation study
Eligibility Criteria
Inclusion
- Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
- Patients aged 19 to 70 years old.
- Patients diagnosed with K\&L grade III/IV knee osteoarthritis
- Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale
Exclusion
- Patients with joint diseases other than osteoarthritis
- Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
- Patients who received intra-articular injections within 6 months prior to the screening
- Patients who have received systemic steroid therapy within 3 months prior to the screening
- Patients who have received immunosuppressive agents within 3 months prior to the screening
- Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
- Patients who are unwilling to use contraception during the clinical trial period
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06539429
Start Date
October 22 2024
End Date
May 15 2026
Last Update
September 22 2025
Active Locations (1)
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1
Seoul National University
Seoul, Seoul, South Korea, 03080