Safety and Tolerability of ACU-4429

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ACU-4429; Drug: matching placebo

• Registration Number: NCT00703183
• Lead Sponsor: Kubota Vision Inc.

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a new investigational drug (ACU-4429) in healthy human volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Is male or female with age ≥ 55 and ≤ 80 years at the time of consent
• Is healthy as determined by medical history and physical examination

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ACU-4429	ACU-4429
2	matching placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	7 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	2 days

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc; 🇺🇸 Dallas, Texas, United States