Title
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 1Lead Sponsor
Achaogen, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HealthyIntervention/Treatment
plazomicin ...Study Participants
39This 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.
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 in escalating doses
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)
