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

January 18, 2013 updated by: Achaogen, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of AEs
Time Frame: 7 days
7 days
Severity of AEs
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of ACHN-975
Time Frame: 2 days
2 days
Urine concentrations of ACHN-975
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Achaogen, Inc.

Collaborators

Defense Medical Research and Development Program

Investigators

  • Study Director: Medical Director, Achaogen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ACHN-975-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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