Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).

Official Title
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A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PG110 (Anti-NGF Monoclonal Antibody) in Patients With Pain Attributed to Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: PG110
* Biological: PG110
* Biological: PG110
* Biological: PG110
* Biological: PG110
* Biological: PG110
* Biological: PG110
* Biological: PG110
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe pain attributed to knee osteoarthritis Exclusion Criteria: Significant comorbidity Significant pain states other than osteoarthritis Concomitant medications that might affect assessments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lowest dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Second dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Third dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Fourth dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Fifth dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Top dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Placebo<br>single, slow intravenous infusion that matches PG110 in appearance | Biological: Placebo<br>* Single, slow intravenous infusion that matches PG110 in appearance<br>|
| Experimental: Seventh Dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|
| Experimental: Eight Dose of PG110<br>single, slow intravenous infusion | Biological: PG110<br>* Single, slow intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and severity of adverse events |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal elimination half-life |  | Three months | 
| Dose proportionality of the area under the serum concentration-time curve |  | Three months | 
| Pain in the index knee |  | Three months | 
| Western Ontario and McMaster Universities questionnaire |  | Three months |