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

NCT01034774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-02-27

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ACHN-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.

DRUG

Placebo (normal saline)

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

Sponsors & Collaborators

  • Achaogen, Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy A Havrilla, MS, RN · Achaogen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-06-30
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034774 on ClinicalTrials.gov