Status:
COMPLETED
Phase 1 Study for Safety of ACHN-490
Lead Sponsor:
Achaogen, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single ...
Eligibility Criteria
Inclusion
- Men or women
- Within normal weight limits
- In good health with normal routine laboratory results
- Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noise
Exclusion
- No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
- No problems with hearing or balance
- No previous injury or surgery the the ears
- No family history of hearing loss before the age of 65
- Not taking any medication other than birth control medication
- Smokers or use of tobacco products
- Recent blood donor
- Allergy ot iodine, shellfish or aminoglycosides (a type of antibiotic)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00822978
Start Date
January 1 2009
End Date
October 1 2009
Last Update
February 27 2012
Active Locations (1)
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1
Jasper Clinic
Kalamazoo, Michigan, United States, 49007