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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01597947
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : January 21, 2013
Sponsor:
Collaborator:
Defense Medical Research and Development Program
Information provided by (Responsible Party):
Achaogen, Inc.

Brief Summary:
This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will take place in the US at one clinical site.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: ACHN-975 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) ACHN-975 in Normal Healthy Volunteers
Study Start Date : May 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Arm A Drug: ACHN-975
Intravenous single dose
Placebo Comparator: Arm B Drug: placebo
Intravenous single dose



Primary Outcome Measures :
  1. Frequency of AEs [ Time Frame: 7 days ]
  2. Severity of AEs [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Plasma concentrations of ACHN-975 [ Time Frame: 2 days ]
  2. Urine concentrations of ACHN-975 [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Body weight between 40 and 100 kilograms (between ~88 pounds and ~220 pounds)
  • Use of contraception
  • Stable health
  • Negative tests for alcohol, tobacco, and drugs of abuse

Key Exclusion Criteria:

  • History of clinically significant disease
  • Pregnancy

Information from the National Library of Medicine

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): NCT01597947


Locations
United States, North Carolina
Investigational Site
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Achaogen, Inc.
Defense Medical Research and Development Program
Investigators
Study Director: Medical Director Achaogen, Inc.

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01597947     History of Changes
Other Study ID Numbers: ACHN-975-001
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013