Safety and Tolerability of ACU-4429
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of action for ACU-4429 in healthy volunteers as studied in NCT00703183?
How does ACU-4429 compare to other investigational drugs in phase 1 trials for safety and tolerability profiles?
Are there specific biomarkers identified in early-phase trials that correlate with adverse events in ACU-4429 studies?
What are the potential drug-drug interaction profiles of ACU-4429 with standard-of-care medications in preclinical models?
How does Kubota Vision Inc.'s ACU-4429 development align with current trends in first-in-human phase 1 drug safety trials?
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc
🇺🇸Dallas, Texas, United States
Covance Clinical Research Unit, Inc🇺🇸Dallas, Texas, United States