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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: ACHN-975; Drug: placebo

• Registration Number: NCT01597947
• Lead Sponsor: Achaogen, Inc.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-15
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	ACHN-975	-
Arm B	placebo	-

Primary Outcome Measures

Name	Time	Method
Frequency of AEs	7 days
Severity of AEs	7 days

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of ACHN-975	2 days
Urine concentrations of ACHN-975	2 days

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Durham, North Carolina, United States