Status:
COMPLETED
Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650
Lead Sponsor:
Avigen
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00364039
Start Date
August 1 2006
Last Update
February 28 2007
Active Locations (1)
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1
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201