---
title: Safety and Tolerability of ACU-4429
nct_id: NCT00703183
overall_status: COMPLETED
phase: PHASE1
sponsor: Kubota Vision Inc.
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00703183.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00703183"
ct_last_update_post_date: 2012-06-27
last_seen_at: "2026-05-12T07:06:34.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Tolerability of ACU-4429

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

**NCT ID:** [NCT00703183](https://clinicaltrials.gov/study/NCT00703183)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 46
- **Lead Sponsor:** Kubota Vision Inc.
- **Conditions:** Healthy
- **Start Date:** 2008-05
- **Completion Date:** 2009-06
- **CT.gov Last Update:** 2012-06-27

## 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.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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
```

## Arms

- **1** (EXPERIMENTAL) — ACU-4429
- **2** (PLACEBO_COMPARATOR) — matching placebo

## Interventions

- **ACU-4429** (DRUG) — administered as a single dose, orally
- **matching placebo** (DRUG) — administered as a single dose, orally

## Primary Outcomes

- **Safety and tolerability** _(time frame: 7 days)_

## Secondary Outcomes

- **Pharmacokinetics** _(time frame: 2 days)_

## Locations (1)

- Covance Clinical Research Unit, Inc, Dallas, Texas, United States

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.covance clinical research unit, inc|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00703183.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00703183*  
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