Status and phase
Conditions
Treatments
About
This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain attributed to osteoarthritis of the knee)
Full description
There will be 8 cohorts of 7 subjects each. Cohorts 1-3 and 8 will be composed of healthy volunteers. Cohorts 4-7 will be composed of osteoarthritis patients. Cohort 4 will be a bridging cohort; osteoarthritis patients in Cohort 4 will receive the same dose as the healthy volunteers in Cohort 3, if deemed safe.
Each subject will be assigned to receive a single dose of LEVI-04 or matching placebo. Each dose will be administered as an intravenous infusion over 30 minutes. Planned doses will start at 0.003 mg/kg in Cohort 1, and may be increased to 3.0 mg/kg in Cohort 8. The planned doses may be changed, depending on the safety, tolerability and pharmacokinetic results after previous doses. The dose selected for each cohort will be determined by the Safety Review Team, following review of all available pharmacokinetic and safety data. For each escalating dose, there will be at least 2 weeks between the start of each cohort (at least 14 days between Day 0 for the last subject in the previous cohort and Day 0 for the first subject in the subsequent cohort), to allow for review of safety, tolerability and pharmacokinetic data. In each cohort, 5 subjects will receive LEVI-04 and 2 subjects will receive matching placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Also for osteoarthritis patients:
History of inflammatory arthritis, including rheumatoid arthritis, seronegative spondyloarthropathy (eg ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), gout, pseudogout in index knee (as diagnosed by appropriate crystals on aspiration or C-reactive protein elevation during attacks (subjects with gout or pseudogout in a joint other than the index knee must have disease that is controlled by medication, with a serum uric acid within the target range; should their index knee flare up during the study, gout must be excluded), metabolic joint disease, endocrinopathy, lupus erythematosus, joint infection, connective tissue disease, septic arthritis
Radiographic evidence of:
History of osteonecrosis / osteoporotic fracture (including minimally traumatic or atraumatic fracture)
History of significant trauma (including sports injury) or surgery to a knee, hip or shoulder within last year
Planned surgery to a knee, hip or shoulder during the study
Fibromyalgia, regional pain caused by lumbar / cervical compression with radiculopathy, or other moderate/severe pain that may confound assessment of knee pain
Intra-articular injection of corticosteroid in the index knee within 3 months, or to any other joint within 1 month of the initial pain assessment
Intra-articular injection of any hyaluronan product in the index knee within 6 months before the initial pain assessment
Any other medical or psychiatric condition, or laboratory abnormality, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate for entry into this study
Primary purpose
Allocation
Interventional model
Masking
56 participants in 16 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal