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

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: NCT01034774
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):
Achaogen, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: ACHN-490 Injection Drug: Placebo (normal saline) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. Lung penetration as estimated from ACHN-490 measured in ELF [ Time Frame: 1 Day ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01034774

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

Responsible Party: Achaogen, Inc. Identifier: NCT01034774     History of Changes
Other Study ID Numbers: ACHN-490-003
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by Achaogen, Inc.:
Human volunteers