Phase 1 Study for Safety of ACHN-490
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
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    plazomicin ...
  • Study Participants

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.
Study Started
Jan 31
Primary Completion
Oct 31
Study Completion
Oct 31
Last Update
Feb 27

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.

ACHN-490 Injection Active Comparator

ACHN-490 Injection in escalating doses

2 Placebo Comparator

Placebo is normal saline


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)
No Results Posted