Safety and Tolerability of ACU-4429

This study is currently recruiting participants.

Verified by Acucela Inc., April 2009

First Received: June 19, 2008 Last Updated: April 2, 2009 History of Changes

Sponsored by:	Acucela Inc.
Information provided by:	Acucela Inc.
ClinicalTrials.gov Identifier:	NCT00703183

Purpose

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

Further study details as provided by Acucela Inc.:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Is receiving or has recently received treatment with a medication disallowed per the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703183

Contacts

Contact: Becky Palchak

425-527-3260 ext 105

Locations

United States, Texas
Covance Clinical Research Unit, Inc	Recruiting
Dallas, Texas, United States, 75247

Sponsors and Collaborators

Acucela Inc.

Investigators

Principal Investigator:

William W Lewis, M.D.

Covance

More Information

No publications provided

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

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009