A Multiple Dose Study to Assess the Safety, Tolerability,... | NCT01870245

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

NCT01870245

Sponsor

Achaogen, Inc.

Status

Terminated

Last Update Posted

Jul 1, 2013Estimated

Enrollment

4Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

ACHN-975
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Not provided

First Submitted Date

May 29, 2013

First Submission Date that Met QC Criteria

Jun 5, 2013

First Posted Date

Jun 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2013

Last Update Posted Date

Jul 1, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACHN-975	Experimental		Drug: ACHN-975
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACHN-975	Drug	Intravenous multiple dose	ACHN-975
placebo

Measure	Description	Time Frame
Frequency of AEs		28 days
Severity of AEs		28 days

Measure	Description	Time Frame
Plasma concentrations of ACHN-975		16 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Achaogen, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Overland Park	Kansas	66211	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000717915	ACHN-975

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided