Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT04677933
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
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
Study:
NCT04677933
Study Brief:
Protocol Section:
NCT04677933