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OpenTrials
Completed

NCT Number: NCT00822978

Phase 1 Study for Safety of ACHN-490

This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men or women
  • Within normal weight limits
  • In good health with normal routine laboratory results
  • Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noise

Exclusion criteria

  • No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
  • No problems with hearing or balance
  • No previous injury or surgery the the ears
  • No family history of hearing loss before the age of 65
  • Not taking any medication other than birth control medication
  • Smokers or use of tobacco products
  • Recent blood donor
  • Allergy ot iodine, shellfish or aminoglycosides (a type of antibiotic)

Treatment and study plan

ACHN-490 Injection vs placebo

Drug

Escalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe.

Primary outcomes

  1. Incident and severity of adverse events

    Time frame: 2 weeks after the last dose for each dose group

Secondary outcomes

  1. Changes from baseline in kidney function, laboratory values, abd vital signs

    Time frame: single and multi-dose

  2. Pharmacokinetic parameters

    Time frame: After single and multiple-dose administration

Sponsors and collaborators

Lead sponsor

Achaogen, Inc.

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-controlled, Parallel-Group, Single and Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-490 Injection Administered Intravenously in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2009
Registry last updated
Feb 27, 2012

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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