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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034774

Enrollment

Registered

2009-12-17

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2012-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Human volunteers

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

* 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)

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026