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

NCT01034774 — Phase 1, Completed, 40 participants, Achaogen, Inc.
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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

RegistryNCT01034774
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment40 (Actual)
SponsorAchaogen, Inc. (Industry)
ConditionsHealthy Volunteers
InterventionsACHN-490 Injection, Placebo (normal saline) (Drug)
Datesstart 2010-01-01, primary completion 2010-06-01, completion 2010-07-01, first posted 2009-12-17, last updated 2012-02-27

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ACHN-490 InjectionActive comparatorDrug: ACHN-490 InjectionACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg.
Placebo is Normal SalinePlacebo comparatorDrug: Placebo (normal saline)Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given.
  • ACHN-490 Injection (Drug): 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.
  • Placebo (normal saline) (Drug), also known as Normal Saline, NS: Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.

+Outcome measures

Primary outcomes

  • Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days [Throughout the study]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, 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)

+Investigators

My Notes