NCT01034774

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Achaogen, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2009-12-17
• Last updated: 2012-02-27