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

A

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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