Phase 1 Study for Safety of ACHN-490

Achaogen, Inc.39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

ACHN-490 Injection vs placeboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Jasper Clinic

Kalamazoo, Michigan, United States

Outcomes

Primary Outcomes

Incident and severity of adverse events

Time frame: 2 weeks after the last dose for each dose group

Secondary Outcomes

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

Time frame: single and multi-dose

Pharmacokinetic parameters

Time frame: After single and multiple-dose administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.