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CompletedNCT01034774Updated Feb 27, 2012

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

A Phase 1 interventional study of ACHN-490 Injection and Placebo (normal saline) in Healthy Volunteers, sponsored by Achaogen, Inc.. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-27.

Sponsored by Achaogen, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Human volunteers
03

In context

Lead sponsor

Achaogen, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • DrugACHN-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.

  • DrugPlacebo (normal saline)

    Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.

    Also known as: Normal Saline, NS

06

What researchers measure

Primary outcomes

  1. Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days

    Time frame: Throughout the study

Secondary outcomes

  1. Lung penetration as estimated from ACHN-490 measured in ELF

    Time frame: 1 Day

  2. Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing

    Time frame: Through 24 hours after the last dose

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01034774
Lead sponsor
Achaogen, Inc.
Responsible party
Sponsor
First posted
Dec 17, 2009
Start date
Jan 2010
Primary completion
Jun 2010
Completion
Jul 2010
Last update
Feb 27, 2012

Study contacts

Nancy A Havrilla, MS, RN
study director · Achaogen, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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