Study drug: OLP-1002~Proposed Dose:~5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15)~10 microgram BIW for 15 days (Day 1, 4, 8, 11 and 15)~Mode of Administration: Subcutaneous injection~The study will consist of 5 time periods:~Screening period: up to14 days~Washout period: 5 days (± 1 day)~Baseline period: 3 days (± 1 day)~Treatment period: 15 days (± 1 day)~Follow-up period: 30 days from last dose (± 5 days)~Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:~Arm A: 10 patients will receive 5 µg BIW OLP-1002~Arm B: 10 patients will receive 10 µg BIW OLP-1002~Arm C: 10 patients will receive Placebo BIW
This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of:~Screening period: up to 14 days (defined as Day -23 to -9)~Washout period: 5 days (± 1 day) (defined as Day -8 to -4)~Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing)~Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing)~Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose)~Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:~Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002~Arm B: 10 patients will receive 10 µg BIW OLP-1002~Arm C: 10 patients will receive Placebo BIW