Phase 1 Study for Safety of ACHN-490

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ACHN-490 Injection vs placebo

• Registration Number: NCT00822978
• Lead Sponsor: Achaogen, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACHN-490 Injection	ACHN-490 Injection vs placebo	ACHN-490 Injection in escalating doses
2	ACHN-490 Injection vs placebo	Placebo is normal saline

Primary Outcome Measures

Name	Time	Method
Incident and severity of adverse events	2 weeks after the last dose for each dose group

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in kidney function, laboratory values, abd vital signs	single and multi-dose
Pharmacokinetic parameters	After single and multiple-dose administration

Trial Locations

Locations (1)

Jasper Clinic; 🇺🇸 Kalamazoo, Michigan, United States