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

Abbott2 sites in 1 country56 target enrollmentStarted: August 2009Last updated: June 7, 2011

Conditions

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Abbott
Enrollment: 56
Locations: 2
Primary Endpoint: The number and severity of adverse events

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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).

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Outcomes

Primary Outcomes

The number and severity of adverse events

Time Frame: Three months

Secondary Outcomes

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)

Investigators

Sponsor

Abbott

Sponsor Class

Industry

Study Sites (2)

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