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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ACHN-490 Injection vs placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • Incident and severity of adverse events [ Time Frame: 2 weeks after the last dose for each dose group ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 39
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACHN-490 Injection
ACHN-490 Injection in escalating doses
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.
Placebo Comparator: 2
Placebo is normal saline
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822978

Locations
United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Achaogen, Inc.
Investigators
Principal Investigator: Carter Brooks, MD Jasper Clinic, Michigan
  More Information

No publications provided

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT00822978     History of Changes
Other Study ID Numbers: ACHN-490-001
Study First Received: January 13, 2009
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Achaogen, Inc.:
healthy
volunteers
subjects

ClinicalTrials.gov processed this record on April 16, 2014