Phase 1 Study for Safety of ACHN-490

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT00822978
First received: January 13, 2009
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ACHN-490 Injection vs placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official 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

Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • Incident and severity of adverse events [ Time Frame: 2 weeks after the last dose for each dose group ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes from baseline in kidney function, laboratory values, abd vital signs [ Time Frame: single and multi-dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: After single and multiple-dose administration ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACHN-490 Injection
ACHN-490 Injection in escalating doses
Drug: ACHN-490 Injection vs placebo
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.
Placebo Comparator: 2
Placebo is normal saline
Drug: ACHN-490 Injection vs placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822978

Locations
United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Achaogen, Inc.
Investigators
Principal Investigator: Carter Brooks, MD Jasper Clinic, Michigan
  More Information

No publications provided

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT00822978     History of Changes
Other Study ID Numbers: ACHN-490-001
Study First Received: January 13, 2009
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Achaogen, Inc.:
healthy
volunteers
subjects

ClinicalTrials.gov processed this record on October 21, 2014