Phase 1 Study for Safety of ACHN-490

NCT ID: NCT00822978

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

ACHN-490 Injection

ACHN-490 Injection in escalating doses

Group Type: ACTIVE_COMPARATOR

ACHN-490 Injection vs placebo

Intervention Type: 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.

2

Placebo is normal saline

Group Type: PLACEBO_COMPARATOR

ACHN-490 Injection vs placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Achaogen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carter Brooks, MD

Role: PRINCIPAL_INVESTIGATOR

Jasper Clinic, Michigan

Locations

Jasper Clinic

Kalamazoo, Michigan, United States

Countries

United States

Other Identifiers

ACHN-490-001

Identifier Type: -

Identifier Source: org_study_id