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

June 28, 2013 updated by: Achaogen, Inc.

A Phase 1 Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 Administered Intravenously to Healthy Volunteers

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • 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 50 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
Placebo Comparator: Placebo
Drug: placebo
Intravenous multiple dose
Experimental: ACHN-975
Drug: ACHN-975
Intravenous multiple dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of AEs
Time Frame: 28 days
28 days
Severity of AEs
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of ACHN-975
Time Frame: 16 days
16 days

Collaborators and Investigators

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

Sponsor

Achaogen, Inc.

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, 2013

Primary Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

July 1, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ACHN-975-002

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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