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NCT01870245 Clinical Trial

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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01870245
Other study ID # ACHN-975-002
Secondary ID
Status Terminated
Phase Phase 1
First received May 29, 2013
Last updated June 28, 2013
Start date May 2013

Study information
Verified date June 2013
Source Achaogen, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ACHN-975
Intravenous multiple dose
• placebo
Intravenous multiple dose

Locations
Country Name City State
United States Investigational Site Overland Park Kansas

Sponsors (1)
Lead Sponsor Collaborator
Achaogen, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of AEs 28 days
Primary Severity of AEs 28 days
Secondary Plasma concentrations of ACHN-975 16 days
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