Phase 1 Study to Determine Safety, Blood PK and Lung Penetration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT01034774
First received: December 16, 2009
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.


Condition Intervention Phase
Healthy Volunteers
Drug: ACHN-490 Injection
Drug: Placebo (normal saline)
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)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Lung Penetration of Intravenous (IV) ACHN-490 in Healthy Subjects

Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lung penetration as estimated from ACHN-490 measured in ELF [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing [ Time Frame: Through 24 hours after the last dose ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACHN-490 Injection
ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg.
Drug: ACHN-490 Injection
ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment.
Placebo Comparator: Placebo is Normal Saline
Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given.
Drug: Placebo (normal saline)
Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
Other Names:
  • Normal Saline
  • NS

  Eligibility

Ages Eligible for Study:   18 Years to 65 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 noises

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 to the ears
  • No family history of hearing loss before the age of 65
  • Not taking any medications other than birth control medication
  • Smokers or use of tobacco products
  • Recent blood donors
  • No excessive alcohol intake or illegal substances
  • No allergy to aminoglycosides (a type of antibiotic)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034774

Sponsors and Collaborators
Achaogen, Inc.
Investigators
Study Director: Nancy A Havrilla, MS, RN Achaogen, Inc.
  More Information

No publications provided

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01034774     History of Changes
Other Study ID Numbers: ACHN-490-003
Study First Received: December 16, 2009
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Achaogen, Inc.:
Human volunteers

ClinicalTrials.gov processed this record on July 22, 2014