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
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2008
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 27, 2012
June 1, 2012
1.1 years
June 19, 2008
June 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
7 days
Secondary Outcomes (1)
Pharmacokinetics
2 days
Study Arms (2)
1
EXPERIMENTALACU-4429
2
PLACEBO COMPARATORmatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Is receiving or has recently received treatment with a medication disallowed per the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit, Inc
Dallas, Texas, 75247, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
William W Lewis, M.D.
Covance
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 23, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 27, 2012
Record last verified: 2012-06