An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age35-75
SponsorAgeless Biotech, Inc.
About this trial
This study is being conducted to evaluate the safety and tolerability of OA-SYS in patients with moderate to severe OA of the knee joint.
Eligibility criteria
Qualifiers
Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2
Ambulatory and in good general health
Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment
Disqualifiers
Known or suspected infection of the target joint
Subjects with surgery for OA in the target joint
Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90 mmHg even with treatment with more than three antihypertensive drugs
Trial design
Treatments tested in this trial
- OA-SYS
Treatment groups
400 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov