NCT00703183
Completed
Phase 1
A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers
Kubota Vision Inc.1 site in 1 country46 target enrollmentMay 2008
Overview
- Phase
- Phase 1
- Intervention
- matching placebo
- Conditions
- Healthy
- Sponsor
- Kubota Vision Inc.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Safety and tolerability
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
2
matching placebo
Intervention: matching placebo
1
ACU-4429
Intervention: ACU-4429
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: 7 days
Secondary Outcomes
- Pharmacokinetics(2 days)
Study Sites (1)
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