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

NCT04677933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-24

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • OliPass Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Andrew Ostor · Emeritus Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2020-12-22
Completion
2020-12-22

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677933 on ClinicalTrials.gov