Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biosplice Therapeutics, Inc.
Age
50–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
