Safety and Tolerability of ACU-4429

This study is currently recruiting participants.

Verified by Acucela Inc., June 2008

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: placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

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:	36
Study Start Date:	May 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ACU-4429	Drug: ACU-4429 ACU-4429 administered as a single oral dose
2: Placebo Comparator placebo	Drug: placebo placebo administered as a single oral dose

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: David McGee, Ph.D., DABT

425-527-3267

Locations

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

Sponsors and Collaborators

Acucela Inc.

More Information

Responsible Party:	Acucela Inc. ( David McGee, Ph.D., DABT / Sr Director, Ophthalmic Drug Development )
Study ID Numbers:	4429-0001
Study First Received:	June 19, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703183
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 15, 2009