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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00364039

Enrollment

Registered

2006-08-15

Start date

2006-08-31

Completion date

Unknown

Last updated

2007-02-28

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

Conditions

Healthy Subjects

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.

Interventions

DRUGAV650

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety	—
Tolerability	—

Secondary

Measure	Time frame
Pharmacokinetic profile	—
Sedation and reaction time changes	—

Countries

United States

Outcome results

None listed

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