None listed
Conditions
Interventions
Drug : This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose block study in subjects with OA knee pain (n=24
6/cohort). In each cohort, subjects will be randomized 4:2 to receive E1K or placebo in a single dose intra articular injection.
Sponsors
Ensol Biosciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male patients or female patients, aged over 40 years as of the date of consent 2. Patients with osteoarthritis according to ACR criteria, having pain in the knee and osteophyte formation in the X-ray examination, and one or more criteria of the following: [ACR Clinical/Radiographic Classification Criteria] - Age over 50 - Morning stiffness for less than 30 minutes - Crepitus on knee motion 3. Kellgren and Lawrence Grade 2 or Grade 3 4. Pain conditions greater than or equal to 40 mm with 100 mm pain VAS during the target lesion activity at Visit 1 (Screening) and Visit 2 5. Single-sided osteoarthritis or both-sided osteoarthritis with target lesion to be designated according to the criteria below; If both knees comply with the selection/exception criteria, the target lesion shall be specified according to the following criteria. 1) Designate higher Kellgren & Lawrence grade side as target lesion. 2) Designate higher100mm pain VAS side as target lesion if the Kellgren & Lawrence grade is the same, 3) Designated as the side to induce clinical symptoms other than pain if the Kellgren & Lawrence grade and the 100mm pain VAS are the same. 4) Right knee is designated as target lesion if all the criteria 1) ~3) above are the same 6. Voluntarily agree in writing to participate in clinical trials
Exclusion criteria
Exclusion criteria: 1. Inflammatory joint disease such as rheumatoid arthritis, septic arthritis, etc. 2. Having conditions that can affect the joints (e.g., gout, recurrent caustic gout, joint fracture, protoplasmosis, pajette disease, Histopathia, Telomere, Hemochromatosis, Wilson's disease, Genetic disease (e.g., Hypermotorosis), collagen gene abnormality). 3. BMI greater than or equal to 30 kg/m2 during screening. 4. Patients who had target region surgery. 5. Before dosing investigational product, one or more of the following are applicable: - NSAIDs or glucosamine, chondroitin sulfate, administered within 14 days prior to dosing - Narcotic or non-narcotic pain medication administered within 1 day prior to dosing - Intra-articular injection of steroids into target region within 3 months prior to dosing - Intra-articular injection of hyaluronic acid, cell therapy, and gene therapy within 6 months prior to dosing 6. Clinically significant abnormal findings with screening tests (laboratory or ECG, vital signs). 7. Clinically severe cardiovascular system, digestive machinery, respiratory system, endocrine system, immune system, central nervous system, and mental illness. 8. HIV antibody test or hepatitis B antigen, hepatitis C antibody test positive. 9. History of drug or alcohol dependence within one year. 10. Those who are likely to conceive during a clinical trial but do not agree to contraception, pregnant, nursing, plan to get pregnant. 11. For male subjects, those who do not agree to ban sperm donation up to 12 weeks with dosing. 12. Participated in other clinical trials within 30 days prior to screening. 13. Any condition that investigator finds it unsuitable to participate in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate safety and tolerability up to 4wks with single knee intra-articular injection of E1K | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of MTD (Maximum Tolerated Dose);Assessment of osteoarthritis symptom before and after dosing. 1) 100 mm pain VAS. 2) IKDC subjective knee evaluation.;The rate and dosage of rescue medication during the entire test period | — |
Countries
Korea, Republic of
Contacts
Public ContactMyung Chul Lee
Seoul National University Hospital
Outcome results
None listed