Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis of the knee TLC599 Dexamethasone DSP
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Detailed description:
Protocol No: TLC599A1001

Name of Finished Product: TLC599

Title of Study:

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee

Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Study duration:

The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.

Arms:
arm 1: 6 mg DSP with 50 μmol PL arm 2: 12 mg DSP with 100 μmol PL

Interventions: intervention 1: TLC599
Intervention descriptions: intervention 1: Single dose via intra-articular injection

Protocol document: