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Clinical Trials/NCT00941746
NCT00941746CompletedPhase 1

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:
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

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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