NCT04677933

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

A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002 in Patients Who Have Pain Due to Moderate to Severe Osteoarthritis in a Hip and/or Knee Joint

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: OliPass Australia Pty Ltd · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Study drug: OLP-1002 Proposed Dose: 1. 5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15) 2. 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

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	A: OLP-1002	10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002
DRUG	B: OLP-1002	10 patients will receive 10 µg OLP-1002 BIW OLP-1002
DRUG	C: Placebo	10 patients will receive Placebo BIW

Timeline

• Start date: 2020-06-03
• Primary completion: 2020-12-22
• Completion: 2020-12-22
• First posted: 2020-12-21
• Last updated: 2020-12-24

Locations

4 sites across 1 country: Australia