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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ACHN-490 Injection; Drug: Placebo (normal saline)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: NS; Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days	Throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Lung penetration as estimated from ACHN-490 measured in ELF	1 Day
Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing	Through 24 hours after the last dose

Collaborators and Investigators

• Sponsor: Achaogen, Inc.
• Investigators: Study Director: Nancy A Havrilla, MS, RN, Achaogen, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 17, 2009

Study Record Updates

• Last Update Posted (Estimate): February 27, 2012
• Last Update Submitted That Met QC Criteria: February 24, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Human volunteers
• Other Study ID Numbers: ACHN-490-003