Phase 1 Study for Safety of ACHN-490

Achaogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ACHN-490 Injection vs placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822978

ACHN-490-001

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

39 participants in 2 patient groups, including a placebo group

ACHN-490 Injection

Active Comparator group

Description:

ACHN-490 Injection in escalating doses

Treatment:

Drug: ACHN-490 Injection vs placebo

2

Placebo Comparator group

Description:

Placebo is normal saline

Treatment:

Drug: ACHN-490 Injection vs placebo