Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 1:37 PM
Study NCT ID:
NCT04677933
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2020-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002
Sponsor:
OliPass Australia Pty Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: