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

This study has been completed.
Sponsor:
Collaborator:
Defense Medical Research and Development Program
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT01597947
First received: May 8, 2012
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteer
 Drug: ACHN-975
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • Frequency of AEs [ Time Frame: 7 days ]
  • Severity of AEs [ Time Frame: 7 days ]

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

Enrollment: 50
Study Start Date: May 2012
Study Completion Date: December 2012
Arms Assigned Interventions
Experimental: Arm A Drug: ACHN-975
Intravenous single dose
Placebo Comparator: Arm B Drug: placebo
Intravenous single dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01597947     History of Changes
Other Study ID Numbers: ACHN-975-001
Study First Received: May 8, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013