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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ACHN-490 Injection
* Drug: Placebo (normal saline)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACHN-490 Injection<br>ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg. | Drug: ACHN-490 Injection<br>* 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.<br>|
| Placebo Comparator: Placebo is Normal Saline<br>Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given. | Drug: Placebo (normal saline)<br>* Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human volunteers