Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941746

Enrollment

Registered

2009-07-20

Start date

2009-08-31

Completion date

2011-01-31

Last updated

2011-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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).

Interventions

BIOLOGICALPG110

Single, slow intravenous infusion

BIOLOGICALPlacebo

Single, slow intravenous infusion that matches PG110 in appearance

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The number and severity of adverse events	Three months

Secondary

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026