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

Achaogen

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo (normal saline)

Drug: ACHN-490 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01034774

ACHN-490-003

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)