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Sponsored by: |
Acucela Inc. |
---|---|
Information provided by: | Acucela Inc. |
ClinicalTrials.gov Identifier: | NCT00703183 |
The purpose of this study is to evaluate the safety and tolerability of a new investigational drug (ACU-4429) in healthy human volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: ACU-4429 Drug: matching placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers |
Estimated Enrollment: | 52 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ACU-4429
|
Drug: ACU-4429
administered as a single dose, orally
|
2: Placebo Comparator
matching placebo
|
Drug: matching placebo
administered as a single dose, orally
|
Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Becky Palchak | 425-527-3260 ext 105 | bpalchak@acucela.com |
United States, Texas | |
Covance Clinical Research Unit, Inc | Recruiting |
Dallas, Texas, United States, 75247 |
Principal Investigator: | William W Lewis, M.D. | Covance |
Responsible Party: | Acucela Inc. ( Ryo Kubota, MD, PhD / President and CEO ) |
Study ID Numbers: | 4429-0001 |
Study First Received: | June 19, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00703183 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy |