Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
Completed · Phase 1 · Has a placebo group
Conditions studied: Moderate to Severe Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT02095548
- Run by
- Biosplice Therapeutics, Inc.
- People needed
- 61
- Starts
- 2014-03-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-12-10
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
- Screening pain criteria sufficient as assessed by WOMAC and VAS scores
- Ability to read and understand the informed consent
You may not qualify if…
- Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
- Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
- Body mass index >40
- Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
- History of malignancy within the last 5 years
- Participation in a clinical research trial within 12 weeks prior
- Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months
- Effusion of the target knee requiring aspiration within 3 months
- Use of electrotherapy or acupuncture for OA within 4 weeks
- Significant and clinically evident misalignment of the target knee
- Any known active infections
- Any chronic condition that has not been well controlled for a minimum of 3 months
Where it is running
- Study site — Tucson, Arizona, United States
- Study site — El Cajon, California, United States
- Study site — Walnut Creek, California, United States
- Study site — Miami, Florida, United States
- Study site — Boston, Massachusetts, United States
- Study site — Duncansville, Pennsylvania, United States
- Study site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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