Phase 1 Study for Safety of ACHN-490

NCT00822978 | Completed Phase 1

• 1 other identifier: ACHN-490-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

healthy; volunteers; subjects

Outcome Measures

Primary Outcomes (1)

• Incident and severity of adverse events

  2 weeks after the last dose for each dose group

Secondary Outcomes (2)

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

  single and multi-dose

• Pharmacokinetic parameters

  After single and multiple-dose administration

Study Arms (2)

ACHN-490 Injection

ACTIVE COMPARATOR

ACHN-490 Injection in escalating doses

Drug: ACHN-490 Injection vs placebo

2

PLACEBO COMPARATOR

Placebo is normal saline

Drug: ACHN-490 Injection vs placebo

Interventions

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.

2; ACHN-490 Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Achaogen, Inc.: lead

Study Sites (1)

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Location

Study Officials

• Carter Brooks, MD

  Jasper Clinic, Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 27, 2012

Record last verified: 2012-02

Locations

US (1)