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

NCT ID: NCT01597947

Last Updated: 2013-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

Group Type EXPERIMENTAL

ACHN-975

Intervention Type DRUG

Intravenous single dose

Arm B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Intravenous single dose

Interventions

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ACHN-975

Intravenous single dose

Intervention Type DRUG

placebo

Intravenous single dose

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* History of clinically significant disease
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Defense Medical Research and Development Program

UNKNOWN

Sponsor Role collaborator

Achaogen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Achaogen, Inc.

Locations

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Investigational Site

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ACHN-975-001

Identifier Type: -

Identifier Source: org_study_id

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