The study consists of two Stages (Stage 1 and Stage 2)~Stage 1: It is an open-label, dose-finding study employing a single ascending dose design to determine appropriate dose level starting dose of OLP-1002 for Stage 2 of the study in participants with moderate to severe pain due to osteoarthritis in a hip and/or knee joint.~Stage 1 consists of following:~Screening period: up to 15 days (± 2 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)~Treatment period: 1 day (defined as Day 1): participants will be subcutaneously administered a single dose of OLP-1002 at the assigned dose level (1 μg, 3 μg, 10 μg, 25 μg, 50 μg, 80 μg)~Follow-up period: 30 days (± 5 days) (defined as Day 2 to 30)~Approximately 30 participants will be enrolled in Stage 1 of the study~Stage 2: The study will be a double-blind, placebo-controlled, parallel-arm study of up to 2 selected single doses of OLP-1002 to evaluate the efficacy of OLP-1002 in the treatment of pain in participants with moderate to severe pain due to osteoarthritis in a knee or hip joint.~Dose levels for Stage 2 will be 1 μg and 2 μg of OLP-1002. Dose selection was based on the conclusions drawn from the internal efficacy data review analysis conducted by Sponsor from data collected in Stage 1 of the study.~Stage 2 consists of following:~Screening Period: up to 14 days (± 2 days)~Baseline Period: 3 days (± 1 day)~Treatment: 1 day (± 2 days)~Follow-up period: 42 days from last dose, D43 (± 5 days)~Approximately 90 participants will be enrolled in Stage 2 of the study
The study is designed to evaluate the efficacy, safety and tolerability of OLP-1002 Subcutaneous (SC) injections for reducing moderate to severe pain due to osteoarthritis in a hip and/or knee joint.