Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034774
|Study Director:||Nancy A Havrilla, MS, RN||Achaogen, Inc.|