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

Phase 1

Terminated

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

• Registration Number: NCT01870245
• Lead Sponsor: Achaogen, Inc.

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 available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-29
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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
Placebo	placebo	-
ACHN-975	ACHN-975	-

Primary Outcome Measures

Name	Time	Method
Frequency of AEs	28 days
Severity of AEs	28 days

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of ACHN-975	16 days

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Overland Park, Kansas, United States