Phase 1/2a Study to Evaluate the Safety and Tolerability Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
CarthroniX, Inc.
Summary
Study is designed to evaluate the safety and effectiveness of a drug called CX-011 to treat pain in patients with osteoarthritis of the knee. Osteoarthritis produces pain in the knee (and other joints) that typically is worsened by activities such as long distance walking and is alleviated by rest.
Description
The primary objective of the study is to assess the safety and tolerability of three escalating doses of CX-011 (100, 300, and 1000 μg) following a single intra-articular administration. Safety assessments will include the incidence and severity of local and systemic adverse events, procedure- and product-related serious adverse events, physical examinations, index knee evaluations, vital signs, electrocardiograms, and safety laboratory tests. Dose-limiting toxicities and the maximum tolerated dose will be determined based on these assessments. Secondary objectives focus on evaluating the pre…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written consent to participate in the study. 2. Males or females 18 years of age or less than 75 years old. 3. Diagnosis OA of the index knee by a combination of clinical and radiographic findings wherein the index knee is self-identified by the patient as the more severe knee and symptoms have persisted for 3 months. 4. Radiographic evidence of OA in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening or during the Screening period. 5. Index knee pain on most days (greater than 15) over the last month 6…
Interventions
- DrugCX-011
CX-011 is a hydrophobic small molecule for intra-articular (IA) administration that is being developed for the treatment of subjects with osteoarthritis of the knee.
Location
- University of Southern CaliforniaLos Angeles, California