NCT01870245

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

May 29, 2013

Last Update Submit

June 28, 2013

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • Frequency of AEs

    28 days

  • Severity of AEs

    28 days

Secondary Outcomes (1)

  • Plasma concentrations of ACHN-975

    16 days

Study Arms (2)

ACHN-975

EXPERIMENTAL
Drug: ACHN-975

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

ACHN-975DRUG

Intravenous multiple dose

ACHN-975
placeboDRUG

Intravenous multiple dose

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of clinically significant disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

ACHN-975

Study Officials

  • Medical Director

    Achaogen, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 6, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

US(1)