drugset / Trial / NCT03754049
A Phase 2, Open Label, Pharmacokinetic (PK) Study of TLC599 in Subjects With Osteoarthritis of the Knee
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is a multi-center, Phase 2, open-label, 1-period, parallel study with 9 cohorts of subjects with osteoarthritis (OA) of the knee enrolled to receive single-dose of TLC599 or Dexamethasone sodium phosphate (DSP) via IA injection and 1 cohort of healthy subjects to receive single-dose of DSP via intravenous (IV) injection.
Timeline
- Start
- 2019-01-21
- Primary completion
- 2023-11-07
- Completion
- 2023-11-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DSP | Other / unclassified | 4 mg | Other |
| Comparator | DSP | Other / unclassified | 10 mg | Other |
| Subject | TLC599 | Other / unclassified | 6 mg | Other |
| Subject | TLC599 | Other / unclassified | 12 mg | Other |