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Report for Clinical Trial NCT01907776

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ME1100 Inhalation Solution (Arbekacin Inhalation Solution) Administered to Healthy Volunteers

This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.

NCT01907776 Healthy

2 Interventions

Name: ME1100 inhalation solution

Description: ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose

Type: Drug

ME1100

Name: ME1100 placebo inhalation solution

Description: Vehicle placebo

Type: Drug

Placebo


Primary Outcomes

Measure: Number of participants with adverse events

Time: from Baseline to Day 8-10

Measure: Number of participants with abnormal physical examinations

Time: from Baseline to Day 8-10

Measure: Number of participants with abnormal 12-lead electrocardiograms

Time: from Baseline to Day 8-10

Measure: Number of participants with abnormal vital signs

Time: from Baseline to Day 8-10

Measure: Number of participants with abnormal safety laboratory measurements

Time: from Baseline to Day 8-10

Secondary Outcomes

Measure: Serum Concentration of ME1100

Time: 5, 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post START of dosing

Measure: Urinary elimination of ME1100

Time: 0-6, 6-12, 12-24, 24-48 and 48-72 hours after single dosing

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 A1555G

heteroplasmy) suggestive of increased risk of hearing loss (MT-RNR1 [A1555G] for mitochondrial 12S ribosomal RNA gene or MT-TS1 [A3243G] for mitochondrial transfer RNA serine 1) - History of parent, sibling or parental sibling reporting hearing loss before age 65 years - History of malignancy - History of clinically significant alcohol or drug abuse - History within last 6 months or current use of any tobacco product including e-cigarettes - Positive drug screen for drugs of abuse - Positive test for HIV, Hepatitis B or Hepatitis C - Use of any prescription or over-the-counter medications (except oral or hormonal contraceptives), herbal supplements, or vitamins within 14 days of Visit 2 - Known hypersensitivity to any aminoglycoside or bacitracin antibiotic - Female of childbearing potential with a positive urine pregnancy test, or currently breast feeding. --- A1555G ---


2 A3243G

heteroplasmy) suggestive of increased risk of hearing loss (MT-RNR1 [A1555G] for mitochondrial 12S ribosomal RNA gene or MT-TS1 [A3243G] for mitochondrial transfer RNA serine 1) - History of parent, sibling or parental sibling reporting hearing loss before age 65 years - History of malignancy - History of clinically significant alcohol or drug abuse - History within last 6 months or current use of any tobacco product including e-cigarettes - Positive drug screen for drugs of abuse - Positive test for HIV, Hepatitis B or Hepatitis C - Use of any prescription or over-the-counter medications (except oral or hormonal contraceptives), herbal supplements, or vitamins within 14 days of Visit 2 - Known hypersensitivity to any aminoglycoside or bacitracin antibiotic - Female of childbearing potential with a positive urine pregnancy test, or currently breast feeding. --- A1555G --- --- A3243G ---



HPO Nodes