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NCT Number: NCT06539429

Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University

Seoul, 03080, South Korea

About this study

Study Design: open-label, single-center, dose-escalation study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

ANT-301

Biological

Administration on Day 1

Primary outcomes

  1. Safety assessment

    Time frame: Week 2, 4, 8, 12, 24 and Month 12

    Number of Adverse events and Laboratory Abnormalities

Secondary outcomes

  1. Pain improvement according to VAS scale measurements

    Time frame: Baseine, Week 4, 8, 12, 24 and Month 12

    The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.

  2. IKDC score

    Time frame: Baseline, Week 4, 8, 12, 24 and 12 months

    IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  3. WOMAC questionnaire score

    Time frame: Baseline, Week 4, 8, 12, 24 and 12 months

    Difference in WOMAC questionnaire scores between baseline and each visit

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study title

Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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