Safety and Tolerability of ACU-4429

Kubota Vision

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ACU-4429; Drug: matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703183

4429-0001

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

ACU-4429

Treatment:

Drug: ACU-4429

2

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: matching placebo