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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT01870245
First received: May 29, 2013
Last updated: June 28, 2013
Last verified: June 2013
  Purpose
This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. 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 Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 Administered Intravenously to Healthy Volunteers

Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • Frequency of AEs [ Time Frame: 28 days ]
  • Severity of AEs [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Plasma concentrations of ACHN-975 [ Time Frame: 16 days ]

Enrollment: 4
Study Start Date: May 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACHN-975 Drug: ACHN-975
Intravenous multiple dose
Placebo Comparator: Placebo Drug: placebo
Intravenous multiple dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870245

Locations
United States, Kansas
Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Achaogen, Inc.
Investigators
Study Director: Medical Director Achaogen, Inc.
  More Information

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01870245     History of Changes
Other Study ID Numbers: ACHN-975-002
Study First Received: May 29, 2013
Last Updated: June 28, 2013

ClinicalTrials.gov processed this record on March 27, 2017