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

Achaogen, Inc.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

ACHN-975DRUG

Intravenous single dose

placeboDRUG

Intravenous single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Investigational Site

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Frequency of AEs

Time frame: 7 days

Severity of AEs

Time frame: 7 days

Secondary Outcomes

Plasma concentrations of ACHN-975

Time frame: 2 days

Urine concentrations of ACHN-975

Time frame: 2 days

Data from ClinicalTrials.gov

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