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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo (normal saline); Drug: ACHN-490 Injection

• Registration Number: NCT01034774
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo is Normal Saline	Placebo (normal saline)	Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given.
ACHN-490 Injection	ACHN-490 Injection	ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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