A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002

• Status: Completed
• Trial end date: 2020-12-22

Summary

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

• Phase: Phase 1

Details

• Lead Sponsor: OliPass Australia Pty Ltd
• Collaborator: Novotech (Australia) Pty Limited