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
  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
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: 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 August 19, 2014