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Phase 1 Study for Safety of ACHN-490

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT00822978
First received: January 13, 2009
Last updated: February 24, 2012
Last verified: February 2012
History of Changes

January 13, 2009
February 24, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00822978 on ClinicalTrials.gov Archive Site
  • Changes from baseline in kidney function, laboratory values, abd vital signs [ Time Frame: single and multi-dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: After single and multiple-dose administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
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)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822978
ACHN-490-001
No
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