Phase 1 Study for Safety of ACHN-490

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822978
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):
Achaogen, Inc.

January 13, 2009
January 15, 2009
February 27, 2012
January 2009
October 2009   (Final data collection date for primary outcome measure)
Incident and severity of adverse events [ Time Frame: 2 weeks after the last dose for each dose group ]
Same as current
Complete list of historical versions of study NCT00822978 on Archive Site
  • Changes from baseline in kidney function, laboratory values, abd vital signs [ Time Frame: single and multi-dose ]
  • Pharmacokinetic parameters [ Time Frame: After single and multiple-dose administration ]
Same as current
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Phase 1 Study for Safety of ACHN-490
A Double-Blind, Randomized, Placebo-controlled, Parallel-Group, Single and Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-490 Injection Administered Intravenously in Healthy Volunteers
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 infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Drug: ACHN-490 Injection vs placebo
Escalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe.
  • Active Comparator: ACHN-490 Injection
    ACHN-490 Injection in escalating doses
    Intervention: Drug: ACHN-490 Injection vs placebo
  • Placebo Comparator: 2
    Placebo is normal saline
    Intervention: Drug: ACHN-490 Injection vs placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Achaogen, Inc.
Achaogen, Inc.
Not Provided
Principal Investigator: Carter Brooks, MD Jasper Clinic, Michigan
Achaogen, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP