Healthy Volunteers Clinical Trial
Official title:
A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Apramycin Administered Intravenously in Healthy Adults.
Verified date | November 2020 |
Source | Juvabis AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a first-in-human study to assess the safety, tolerability and pharmacokinetics of escalating single doses of apramycin. This trial will be conducted as a single ascending dose trial in up to 5 sequential dose cohorts (group-comparison). Each cohort will consist of 8 healthy subjects, 6 will receive apramycin and 2 placebo.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 16, 2020 |
Est. primary completion date | July 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy male and female subjects of non-childbearing potential, 18-45 years of age (both inclusive), body mass index 18.0 - 29.9 kg/m2 (inclusive) and body weight from 50 to 100 kg (inclusive). - Glomerular filtration rate (GFR) = 90 mL/min /1.73 m2. - Subjects with systemic hearing, with air conduction thresholds no worse than 20 decibels (dB) hearing loss for the frequencies 0.5-1-2-4-6-8 kilohertz (kHz) bilaterally and, no threshold asymmetry = 20 dB at any frequency, normal (reproducibility 70% or better) transient evoked otoacoustic emissions (TEOAE). - From the signing of the informed consent until the last follow-up visit, subjects must be willing to avoid exposure to loud noise and Subjects must be willing to avoid excessive physical exercise within 48 h prior to dosing. - Normal blood pressure and pulse rate, ECG recording without clinically significant abnormalities. - Thyroid-stimulating hormone, free triiodothyronine and free thyroxine within the reference ranges. - Having had no febrile or infectious illness for at least 7 days prior to the first administration of the Investigational medicinal product (IMP) of the study. - Normal microscopic findings in the ears, normal tympanic membrane mobility and stapedial reflex present. Exclusion Criteria: - Vegetarian or vegan. - Demonstrating excess in xanthine consumption. - More than low-risk alcohol consumption (men: =24 g of pure alcohol regularly per day; women: =12 g of pure alcohol regularly per day). - Any history of alcohol or drug abuse or a positive urine drug screen test. Positive alcohol breath test. - Consumption of xanthine-containing food or beverages within 48 h before dosing. - Smokers smoking more than 10 cigarettes or equivalent per day. - Exposure to loud noise within 3 days prior to drug administration. - Taking any medication on a regular basis, with the exception of solitary doses of up to 1000 mg paracetamol. - Use of any investigational drug product within 30 days or 5 half-lives before screening. - Use of aminoglycosides or other antibiotics within 3 months prior to screening. - Use of neuromuscular blocking agents within 1 week or 5 half-lives prior to screening. - Use of potentially nephrotoxic medication 2 weeks prior to the drug administration. - Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as hay fever with ongoing symptoms. - Any history of hypersensitivity to aminoglycosides. - Any history or signs of acute, chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, neuromuscular disorders, endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency. - Problems with hearing and/or balance. - Previous injury or surgery to the middle or inner ears, family history of hearing loss before the age of 60. - Genetic predisposition to aminoglycoside-driven ototoxicity. - Laboratory values outside the reference range that are of clinical relevance. - Positive test for HIV antibodies, hepatitis B-virus surface antigen, or anti-hepatitis C-virus antibodies. - Blood or plasma donation of 500 mL within 3 months or more than 100 mL within 30 days before signing an informed consent to this trial. - Judged by the investigator to have occupational noise exposure of high risk during the trial. - Positive test for SARS-CoV-2. |
Country | Name | City | State |
---|---|---|---|
Germany | CRS Clinical Research Services Mannheim GmbH | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Juvabis AG | Innovative Medicines Initiative |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Type and incidence of treatment-emergent adverse events (TEAEs) until 2 weeks after dosing. | until 2 weeks after dosing | ||
Primary | Type and incidence of TEAEs related to auditory and vestibular function tests. | until 3 months after dosing | ||
Primary | Number of subjects with clinically significant vital sign measurement blood pressure. | Frequency is defined as number of subjects with clinically significant observations. | until 2 weeks after dosing | |
Primary | Number of subjects with clinically significant vital sign measurement pulse rate. | Frequency is defined as number of subjects with clinically significant observations. | until 2 weeks after dosing | |
Primary | Number of subjects with clinically significant observation in physical examination. | Frequency is defined as number of subjects with clinically significant observations. | until 2 weeks after dosing | |
Primary | Number of subjects with clinically significant changes in clinical laboratory parameters. | Frequency is defined as number of subjects with clinically significant observations. | until 2 weeks after dosing | |
Primary | Number of subjects with clinically significant changes in ECG parameters. | ECG parameters include heart rate and PQ, QT, RS. Frequency is defined as number of subjects with clinically significant observations. | until 2 weeks after dosing |
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