Safety and Tolerability of ACU-4429

A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703183

Enrollment

Registered

2008-06-23

Start date

2008-05-31

Completion date

2009-06-30

Last updated

2012-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGACU-4429

administered as a single dose, orally

DRUGmatching placebo

administered as a single dose, orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	7 days

Secondary

Measure	Time frame
Pharmacokinetics	2 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026