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Completed

NCT Number: NCT01597947

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACHN-975

Drug

Intravenous single dose

Placebo

Drug

Intravenous single dose

Primary outcomes

  1. Frequency of AEs

    Time frame: 7 days

  2. Severity of AEs

    Time frame: 7 days

Secondary outcomes

  1. Plasma concentrations of ACHN-975

    Time frame: 2 days

  2. Urine concentrations of ACHN-975

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Achaogen, Inc.

Industry

Collaborators

  • Defense Medical Research and Development Program

Registry information

Official study title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) ACHN-975 in Normal Healthy Volunteers

Important dates

Study start
2012
Study completion
2012
First posted
May 15, 2012
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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