Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650

A Phase 1 Double-Blind, Placebo-Controlled Single Center Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Dose and Multiple Dose Escalations of AV650 in Healthy Subjects

The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: AV650

• Study Type: Interventional
• Enrollment: 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • SNBL Clinical Pharmacology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-smoking
• Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage

Exclusion Criteria:

• Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS)
• History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease
• History of HIV or Hepatitis B
• History of symptomatic hypotension
• History of mental illness, drug addiction, drug abuse or alcoholism
• History of cancer
• History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis)
• Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids
• History of gastric or duodenal ulcer disease
• History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1
• Female subjects who are pregnant or nursing
• Have donated blood within 90 days of Study Day -1
• Have received an investigational drug within 90 days of Screening
• Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Tolerability

Secondary Outcome Measures

Outcome Measure
Pharmacokinetic profile
Sedation and reaction time changes

Collaborators and Investigators

• Sponsor: Avigen
• Investigators: Principal Investigator: Stephan A. Bart, M.D., SNBL Clinical Pharmacology Center

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 14, 2006
• First Submitted That Met QC Criteria: August 14, 2006
• First Posted (Estimate): August 15, 2006

Study Record Updates

• Last Update Posted (Estimate): February 28, 2007
• Last Update Submitted That Met QC Criteria: February 27, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: AV650-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No