Evaluating ANT-301 for knee osteoarthritis treatment
Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients
This study is testing a new treatment called ANT-301 to see if it can help people with severe knee osteoarthritis feel less pain and improve their knee function.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Anterogen Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06539429 on ClinicalTrials.gov |
What this trial studies
This phase I open-label study aims to assess the efficacy and safety of ANT-301 in patients suffering from knee osteoarthritis classified as K/L Grade III/IV. The study will be conducted as a single-center, dose-escalation trial, allowing researchers to monitor the effects of varying doses of ANT-301 on pain and function in the knee. Participants will be closely observed for any adverse effects and overall improvements in their condition. The study is designed to gather preliminary data that could inform larger trials in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 70 with K/L grade III/IV knee osteoarthritis and a pain score of 40mm or higher.
Not a fit: Patients with other joint diseases, recent knee surgeries, or those who have received certain therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve mobility for patients with advanced knee osteoarthritis.
How similar studies have performed: While this approach is novel, similar studies targeting knee osteoarthritis have shown promise in evaluating new treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form 2. Patients aged 19 to 70 years old. 3. Patients diagnosed with K\&L grade III/IV knee osteoarthritis 4. Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale Exclusion Criteria: 1. Patients with joint diseases other than osteoarthritis 2. Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening 3. Patients who received intra-articular injections within 6 months prior to the screening 4. Patients who have received systemic steroid therapy within 3 months prior to the screening 5. Patients who have received immunosuppressive agents within 3 months prior to the screening 6. Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening 7. Patients who are unwilling to use contraception during the clinical trial period
Where this trial is running
Seoul
- Seoul National University — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hyuksoo Han, MD. Ph D
- Email: oshawks7@snu.ac.kr
- Phone: +82-02-
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.