Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biosplice Therapeutics, Inc.; Samumed LLC
• Treatments: Lorecivivint

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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