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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822978

Enrollment

Registered

2009-01-15

Start date

2009-01-31

Completion date

2009-10-31

Last updated

2012-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy, volunteers, subjects

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.

Interventions

DRUGACHN-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026