Trials / Completed
CompletedNCT02095548
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Biosplice Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SM04690, 0.03mg/2mL | |
| DRUG | SM04690, 0.07mg/2mL | |
| DRUG | SM04690, 0.23mg/2mL | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2014-03-26
- Last updated
- 2015-12-10
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02095548. Inclusion in this directory is not an endorsement.