NCT05216341

Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint

A 2-stage, Phase 2a Study to Evaluate the Efficacy, Safety, and Tolerability of OLP-1002 Subcutaneous Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in a Hip and/or Knee Joint

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: OliPass Corporation · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	OLP-1002	Stage 1: A total of 5 participants will be enrolled in each arm in Stage 1. Each participant will receive one single dose of OLP-1002 by subcutaneous injection. Stage 2: Up to 90 participants will be randomised on Day 1 to one of 3 treatment arms, in the ratio of 1:1:1 to receive one single dose of OLP-1002 (1 µg or 2 µg) or placebo. Each participant will receive one single dose of OLP-1002 or placebo by subcutaneous injection.

Timeline

• Start date: 2021-01-11
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2022-01-31
• Last updated: 2024-05-10

Locations

7 sites across 1 country: Australia