A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis.

Sponsor
ICM Co. Ltd.
Study ID
NCT05454566
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ICM-203 — GENETIC
    Intra-articular injection

Study Details

The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 into the knee of subjects with mild to moderate knee osteoarthritis (OA). Approximately 6 to 18 subjects will be enrolled into 3 successive dose-escalating groups in a 3+3 study design, whereby 3 study subjects in each group will be dosed sequentially with ICM-203 and 3 additional subjects will be dosed at the same dose level if a dose limiting toxicity (DLT) occurs in any of the first 3 subjects.

Key Dates

First listed
Jul 12, 2022
Start date
Nov 15, 2026
Status verified
Mar 2026
Primary completion
May 15, 2027
Completion
Nov 15, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: ICM-203 (Low dose)
    3 to 6 subjects will receive a single intra-articular injection of ICM-203 at 6x10e12 vg into the target knee at Day 1
  • Experimental: Group 2: ICM-203 (Medium dose)
    3 to 6 subjects will receive a single intra-articular injection of ICM-203 at 2x10e13 vg into the target knee at Day 1
  • Experimental: Group 3: ICM-203 (High dose)
    3 to 6 subjects will receive a single intra-articular injection of ICM-203 at 6x10e13 vg into the target knee at Day 1

Primary Outcome Measure

Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 52 ]

Central Contacts

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