Phase 1 Study for Safety of ACHN-490

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ACHN-490 Injection vs placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACHN-490 Injection<br>ACHN-490 Injection in escalating doses | Drug: ACHN-490 Injection vs placebo<br>* 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.<br>|
| Placebo Comparator: 2<br>Placebo is normal saline | Drug: ACHN-490 Injection vs placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident and severity of adverse events |  | 2 weeks after the last dose for each dose group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, volunteers, subjects