Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
|ClinicalTrials.gov Identifier: NCT01034774|
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : February 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: ACHN-490 Injection Drug: Placebo (normal saline)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||July 2010|
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
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 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)
Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
- Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days [ Time Frame: Throughout the study ]
- Lung penetration as estimated from ACHN-490 measured in ELF [ Time Frame: 1 Day ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034774
|Study Director:||Nancy A Havrilla, MS, RN||Achaogen, Inc.|