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AzTrials

Bacterial InfectionPhase 1NCT05590728

Safety of Intravenous Apramycin in Adults

A Phase 1 study testing Apramycin (EBL-1003) in people with Bacterial Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase I, open label study of a single dose of 30 mg/kg of apramycin administered intravenously (IV) over 30 (+/- 5) minutes. Twenty subjects will be enrolled in the study to one of 5 cohorts, T1-T5, each corresponding to a timepoint after initiation of infusion at which a single fiberoptic bronchoscopy with… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Bacterial Infection
What is being tested?
Apramycin (EBL-1003)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
16 Jun 2023to 22 Oct 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject reads and signs the Informed Consent Form (ICF) and agree to have bronchoscopy with bronchoalveolar lavage under sedation or light anesthesia and comply with study procedures.
  • Healthy male or non-pregnant, non-lactating female subjects 18 to 45 years of age (both inclusive) at the time of dosing.
  • Note 1: Determined by medical history (MH), medication use, physical examination (PE), and vital signs, clinical laboratory tests and 12-lead ECG within reference ranges at Screening and Day-2. (See Sections 8.1 and 8.2; and Appendix B, Table 2, Table 3 and Table 4 and the study-specific MOP.)
  • Exceptions to BP, HR and laboratory test values being with normal ranges are:
  • Abnormal HR and BP on first measurement may be repeated twice more with the subject resting between measurements for at least 5 min according to Section 8.1.6.
  • Subjects with baseline HR >/= 45 to 50 bpm may be accepted if otherwise healthy adults with known history of asymptomatic bradycardia.
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  • Subjects with baseline SBP up to 140 mmHg and DBP up to 90 mmHg may be accepted if otherwise healthy.
  • A laboratory value that is Grade 1 will be allowed if not considered to be clinically significant by the investigator, with the exception of ALT, AST, AP, BUN, urine protein, serum creatinine or estimated glomerular filtration rate (eGFR) <70 mL/min /1.73 m^2 by the Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation.
  • Female subjects of childbearing potential should use highly effective methods of contraception from the time of screening to 30 days after dosing.
  • Note 1: A female is considered of childbearing potential unless post-menopausal (defined as history of >/=1 year of spontaneous amenorrhea and a FSH level >40 IU/L), or permanently surgically sterilized.
  • Note 2: Highly effective contraceptive methods include: (a) surgical sterilization methods, such as tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful tubal obliteration (e.g., Essure(R)) with documented radiological confirmation test at least 90 days after the procedure, or (b) long-acting reversible contraception, such as progestin-releasing subdermal implants, copper intrauterine devices (IUDs), levonorgestrel-releasing IUDs.
  • Note 3: A subject who is not sexually active and abstains from sexual intercourse can be enrolled and abstinence documented.
  • Males, including vasectomized men, having sexual intercourse with women of childbearing potential must agree to consistent use of condoms from IMP administration through at least 30 days after dosing, and must also agree to not donate sperm during this same time period.
  • Note: A subject who is not sexually active and abstains from sexual intercourse can be enrolled and abstinence documented.
  • BMI 18.0 to 32.0 kg/m^2 (inclusive) and body weight not less than 50 kg.
  • Subjects with normal hearing, i.e., symmetric hearing with air conduction thresholds no worse than 20 dB hearing loss for the frequencies 0.5-1-2-4-6-8 kHz bilaterally.
  • Normal (reproducibility 70% or better) of distortion product otoacoustic emissions (DPOAEs).
  • Note: Absence of DPOAEs at no more than two consecutive or non-consecutive DPOAEs in each ear is acceptable.
  • Normal otoscopic findings in the ears, normal tympanic membrane mobility and stapedial reflex present.
  • From the signing of the informed consent until the last follow-up visit, subjects must be willing to avoid exposure to loud music or noise.
  • Note: Noise avoidance to include continuous usage of earpieces at high volume, attending loud concerts or dance events, or using firearms or attending fireworks.
  • Normal lung function with Forced Expiratory Volume in the first second (FEV1) predicted >/= 80% and FEV1/Forced Vital Capacity (FVC) > 70%.
  • Subjects must be willing to avoid excessive physical exercise within 48 h prior to dosing until discharge from the CTU on Day 3, and 24 h before each follow-up visit (Day 14 +/- 3 days and Day 30 +/- 4 days).
  • No history of acute febrile or infectious illness for at least 7 days prior to the administration of the IMP.
  • No history of lower respiratory tract infection within 4 weeks prior to screening.
  • Have adequate venous access for infusion and blood draws.

Who cannot join

  • All must be answered NO for the subject to be eligible for study participation:
  • Lactating females.
  • Medical and surgical history:
  • Any history of hypersensitivity to aminoglycosides.
  • Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis.
  • Any history of seasonal allergies with ongoing symptoms for more than a week prior to dosing requiring glucocorticoids and/or frequent use of antihistamines for treatment.
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  • Any history of a chronic condition that may increase risk to subject or interfere with endpoint assessment, or any unstable chronic disease.
  • Note 1: Unstable chronic disease is defined by need for frequent medical interventions that lead to a change in medications and/or required hospitalization, surgery or an invasive procedure or emergency department/urgent care visit.
  • Note 2: Any chronic disease, that has been diagnosed within 90 days of screening is excluded.
  • History of any psychiatric medical condition that has required hospitalization in the last 5 years or subject is considered psychologically unstable by the investigator.
  • History of acute or chronic problems with hearing and/or balance in the last 24 months.
  • -Note: These include but not limited to use of hearing aid, head injury leading to otologic damage, tumor of the head or neck, autoimmune disease of the inner ear, tinnitus, vestibular disease, auditory neurinoma, endolymphatic hydrops and/or Meniere's disease, perilymphatic fistula, otitis media, labyrinthitis, sudden hearing loss, known retrocochlear hearing impairment, conductive hearing loss exceeding 10 dB at any frequency, ear canal and/or middle ear disease including inflammation or effusion, pathological tympanometry.
  • Past injury or surgery to the middle or inner ears.
  • -Note: Myringotomy or tympanic tube insertion in childhood with complete healing and normal hearing test are excluded.
  • Family history of hearing loss before the age of 60.
  • Subjects who have had previous intolerance or contraindications to medications applied for sedation or anesthesia during bronchoscopy.
  • -Note: These include benzodiazepines or topical anesthetic agents (lidocaine or xylocaine) including reversal agents such as flumazenil.
  • Laboratory examinations:
  • Positive serum pregnancy test for women at screening or urine pregnancy test at check-in.
  • Positive test for HIV antibodies, hepatitis B-virus surface antigen (HBsAg), or anti-hepatitis C-virus antibodies (anti-HCV).
  • Prior medication:
  • Use of any prescription or non-prescription medication prior to the dose of IMP
  • -Note: Exceptions are hormonal contraceptives, which are permitted throughout the study, and solitary doses of up to 1,000 mg paracetamol.
  • Use of any investigational drug product within 30 days or 5 half-lives (whichever is longer) before dosing.
  • Planned participation in a clinical research study that requires treatment with a study drug or blood draws or other invasive assessments during the study period (screening until final visit).
  • Lifestyle restrictions:
  • More than low-risk alcohol consumption (men: >/= 24 g of pure alcohol regularly per day; women: >/=12g of pure alcohol regularly per day) for the previous 3 months.
  • Any history of alcohol or drug abuse or positive alcohol breathalyzer test.
  • Suspicion of illicit drug use / abuse or positive urine drug screen test.
  • History of >/=10 pack-years smoking, or history of any nicotine use in the 6 months before check-in (Day -2) or positive urine cotinine screen at check-in.
  • Note 1: Nicotine products include cigarettes, e-cigarettes, pipe, cigar, chewing tobacco, nicotine patch.
  • Note 2: A positive urine cotinine at screening is allowed if negative at check-in (Day -2).
  • Caffeinated beverages/foods are prohibited within 48 hours before dosing to Day 3 of the trial. During the follow up period, consumption is restricted to not more than 3 cups or equivalent per day.
  • Judged by the investigator to have occupational noise exposure of high risk during the trial (e.g., construction site workers, military workers, etc.).
  • Blood or plasma donation of 500 mL within 3 months or more than 100 mL within 30 days before signing informed consent or planned donation prior to completion of this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Alliance for Multispecialty Research, LLC - Knoxville

    Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: A Phase I, Open-label Study to Assess Lung Pharmacokinetics and Safety of a Single Dose of Apramycin Administered Intravenously in Healthy Adult Subjects

A Phase I, open label study of a single dose of 30 mg/kg of apramycin administered intravenously (IV) over 30 (+/- 5) minutes. Twenty subjects will be enrolled in the study to one of 5 cohorts, T1-T5, each corresponding to a timepoint after initiation of infusion at which a single fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) is performed. There will be 4 subjects per cohort. Cohort T5 will be enrolled after plasma and lung apramycin concentrations and preliminary PK data analysis are completed in cohorts T1-T4. Enrollment and dosing will be determined by bronchoscopy schedule. For each cohort, if 2 subjects are scheduled to receive study drug on the same day, the dose will be administered sequentially at least 2 hours apart. The primary objective is to assess plasma pharmacokinetic (PK) profile of apramycin and lung penetration of apramycin in epithelial lining fluid (ELF) and alveolar macrophages (AM) after single intravenous (IV) apramycin dose of 30 mg/kg in healthy subjects.

Read the detailed description

A Phase I, open label study of a single dose of 30 mg/kg of apramycin administered intravenously (IV) over 30 (+/- 5) minutes. Twenty subjects will be enrolled in the study to one of 5 cohorts, T1-T5, each corresponding to a timepoint after initiation of infusion at which a single fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) is performed. There will be 4 subjects per cohort. Cohort T5 will be enrolled after plasma and lung apramycin concentrations and preliminary PK data analysis are completed in cohorts T1-T4. Enrollment and dosing will be determined by bronchoscopy schedule. For each cohort, if 2 subjects are scheduled to receive study drug on the same day, the dose will be administered sequentially at least 2 hours apart. The primary objective is to assess plasma pharmacokinetic (PK) profile of apramycin and lung penetration of apramycin in epithelial lining fluid (ELF) and alveolar macrophages (AM) after single intravenous (IV) apramycin dose of 30 mg/kg in healthy subjects. The secondary objectives are to 1) assess the safety of single IV administration of 30 mg/kg apramycin in healthy subject and 2) to assess changes in otoacoustic testing.

Being tested
Apramycin (EBL-1003)
Keywords
Apramycin, Lung Pharmacokinetics, Open-label, Phase I, Respiratory
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apramycin (EBL-1003)Drug

    A mono-substituted 2-deoxystreptamine comprising a unique bicyclic octadiose moiety. It is a crystalline free base of the amoniglycoside apramycin.

Study groups in NCT05590728
Study groupRoleWhat they receive
T1ExperimentalSubjects 18 to 45 years of age to receive 30 mg/kg apramycin dose administered intravenously (IV) in a forearm vein over 30 min (+/- 5 min) using a syringe or infusion pump. 0.5 h (+/- 5 min) after dosing a single bronchoscopy with bronchoalveolar lavage (BAL) will be performed to analyze concentration of apramycin in BAL. N=4
Receives: Drug: Apramycin (EBL-1003)
T2ExperimentalSubjects 18 to 45 years of age to receive single 30 mg/kg apramycin dose administered intravenously (IV) in a forearm vein over 30 min (+/- 5 min) using a syringe or infusion pump. 2 h (+/- 5 min) after dosing a single bronchoscopy with bronchoalveolar lavage (BAL) will be performed to analyze concentration of apramycin in BAL. N=4
Receives: Drug: Apramycin (EBL-1003)
T3ExperimentalSubjects 18 to 45 years of age to receive single 30 mg/kg apramycin dose administered intravenously (IV) in a forearm vein over 30 min (+/- 5 min) using a syringe or infusion pump. 4 h (+/-10 min) after dosing a single bronchoscopy with bronchoalveolar lavage (BAL) will be performed to analyze concentration of apramycin in BAL. N=4
Receives: Drug: Apramycin (EBL-1003)
T4ExperimentalSubjects 18 to 45 years of age to receive single 30 mg/kg apramycin dose administered intravenously (IV) in a forearm vein over 30 min (+/- 5 min) using a syringe or infusion pump. 8 h (+/- 15 min) after dosing a single bronchoscopy with bronchoalveolar lavage (BAL) will be performed to analyze concentration of apramycin in BAL. N=4
Receives: Drug: Apramycin (EBL-1003)
T5ExperimentalSubjects 18 to 45 years of age to receive single 30 mg/kg apramycin dose administered intravenously (IV) in a forearm vein over 30 min (+/- 5 min) using a syringe or infusion pump. Cohort T5 will be enrolled after plasma and lung apramycin concentrations and preliminary PK data analysis are completed in cohorts T1-T4 24 h (+/- 1 h) after dosing a single bronchoscopy with bronchoalveolar lavage (BAL) will be performed to analyze concentration of apramycin in BAL. N=4
Receives: Drug: Apramycin (EBL-1003)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration-time Curve From Time Zero to 8 h (AUC 0-8) of Total Apramycin in Epithelial Lining Fluid (ELF) and Alveolar Macrophage (AM)

    AUC 0-8 (ug*h/mL) was estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF and AM concentration at one time point, so the PK parameters for ELF and AM were calculated using the geometric mean (GM) concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF and AM across all participants.

    Measured: 0 h through 8 h post dose

  2. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of Total Apramycin in ELF and AM

    AUC 0-inf (ug*h/mL) was estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF and AM concentration at one time point, so the PK parameters for ELF and AM were calculated using the geometric mean (GM) concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF and AM across all participants.

    Measured: 0 h through 8 h post dose

  3. Maximum Concentration (Cmax) of Total Apramycin in ELF and AM

    Cmax (ug/mL) was estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF and AM concentration at one time point, so the PK parameters for ELF and AM were calculated using the geometric mean (GM) concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF and AM across all participants.

    Measured: 0 h though 8 h post dose

  4. Time of Maximum Concentration (Tmax) of Total Apramycin in ELF and AM

    Tmax (h) was estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF and AM concentration at one time point, so the PK parameters for ELF and AM were calculated using the geometric mean (GM) concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF and AM across all participants.

    Measured: 0 h through 8 h post dose

  5. Terminal Elimination Half-Life (t1/2) of Total Apramycin in ELF and AM

    t1/2 (h) was estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF and AM concentration at one time point, so the PK parameters for ELF and AM were calculated using the geometric mean (GM) concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF and AM across all participants.

    Measured: 0 h through 8 h post dose

  6. Area Under the Concentration-time Curve From Time Zero to 8 h (AUC 0-8) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of AUC 0-8 (h*ug/mL). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study.

    Measured: 0 h through 8 h post dose

  7. Area Under the Concentration-time Curve From Time Zero to 24 h (AUC 0-24) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of AUC 0-24 (h*ug/mL). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study.

    Measured: 0 h through 24 h post dose

  8. Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration Above the Lower Limit of Quantitation (AUC 0-last) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of AUC (0-last) (h*µg/mL). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study.

    Measured: 0 h through 60 h post dose

  9. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of AUC (0-Inf) (h*µg/mL). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study. AUC 0-Inf was estimated for plasma concentration data with the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) = 0.90 and includes at least 3 timepoints after time to maximum concentration (Tmax).

    Measured: 0 h through 60 h post dose

  10. Maximum Concentration (Cmax) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of Cmax (ug/mL). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study.

    Measured: 0 h though 60 h post dose

  11. Time of Maximum Concentration (Tmax) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of Tmax (h). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study.

    Measured: 0 h through 60 h post dose

  12. Terminal Elimination Half-Life (t1/2) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of t1/2 (h). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study. t1/2 was estimated for plasma concentration data with the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) = 0.90 and includes at least 3 timepoints after time to maximum concentration (Tmax).

    Measured: 0 h through 60 h post dose

  13. Central Volume of Distribution (Vd) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of Vd (L/kg). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study. Vd was estimated for plasma concentration data with the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) = 0.90 and includes at least 3 timepoints after time to maximum concentration (Tmax).

    Measured: 0 h to 60 h post dose

  14. Total Clearance (CLT) of Total Apramycin in Plasma

    Geometric mean (GM) and coefficient of variation as a percent (CV%) of CLT (L/h/kg). PK parameters were estimated from the total apramycin plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MC/MS bioanalytical assay for plasma samples collected during the study. CLT was estimated for plasma concentration data with the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) = 0.90 and includes at least 3 timepoints after time to maximum concentration (Tmax).

    Measured: 0 h through 60 h post dose

  15. Ratio of ELF to Plasma and AM to Plasma Apramycin Exposure Parameters

    The ratios for Cmax (ug/mL), AUC 0-8 (ug*h/mL), and AUC 0-inf (ug*h/mL) of ELF to plasma and AM to plasma were calculated by dividing the Cmax (ug/mL), AUC 0-8 (ug*h/mL), and AUC 0-inf (ug*h/mL) of ELF and AM by the Cmax (ug/mL), AUC 0-8 (ug*h/mL), and AUC 0-inf (ug*h/mL) of total apramycin in plasma, respectively. All PK parameters were estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF and AM concentration at one time point, so the PK parameters for ELF and AM were calculated using the GM concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF and AM across all participants. The PK parameters for total apramycin in plasma were calculated using the GM result of the total apramycin in plasma concentrations at the corresponding BAL time point.

    Measured: 0 h through 8 h post dose

Secondary outcomes (10)

  1. Frequency of Serious Adverse Events (SAEs)

    Number of participants that experience any SAEs from Day 1 to Day 30. An AE is considered serious if, in the view of either the site principal investigator or sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

    Measured: Day 1 through Day 30

  2. Frequency of Treatment-emergent Adverse Events (TEAEs)

    The number of participants who experienced at least one unsolicited TEAE of any severity and relatedness. Any medical condition that was present at screening was considered a baseline finding and not reported as an AE. However, if the grade increased at any time during the trial such that it met the AE definition, it was recorded as an AE.

    Measured: Day 1 through Day 30

  3. Frequency of Abnormal Physical Exam Findings

    Abnormal physical exam findings through Day 14. Physical exams included assessment of head, eyes, ears, nose, and throat; heart, lungs, abdomen, skin, musculoskeletal system, and lymph nodes.

    Measured: Day 1 through Day 14

  4. Frequency of Abnormal Vital Sign Findings

    Abnormal vital sign findings through Day 14. Vital sign measurements include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oral temperature. If a vital sign finding met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.

    Measured: Day 1 through Day 14

  5. Frequency of Abnormal Chemistry Lab Measurements

    Abnormal chemistry laboratory findings through Day 14. Graded chemistry laboratory measurements include sodium, potassium, glucose (fasting), blood urea nitrogen, creatinine, calcium, magnesium, carbon dioxide, albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, and direct bilirubin. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

    Measured: Day 1 through Day 14

  6. Frequency of Abnormal Hematology Lab Measurements

    Abnormal hematology laboratory findings through Day 14. Graded hematology laboratory measurements include hemoglobin, platelet count, white blood cells, neutrophils, lymphocytes, eosinophils, basophils, and monocytes. If a clinical hematology laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

    Measured: Day 1 through Day 14

  7. Frequency of Abnormal Coagulation Lab Measurements

    Abnormal coagulation laboratory findings through Day 14. Graded coagulation laboratory measurements include activated partial thromboplastin time, prothrombin time, and prothrombin international normalized ratio. If a clinical coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

    Measured: Day 1 through Day 14

  8. Frequency of Abnormal Urinalysis Lab Measurements

    Abnormal urinalysis laboratory findings through Day 14. Urinalysis laboratory measurements include routine dipstick testing of clean-catch urine for blood, protein, and glucose. If urine dipstick was abnormal, urine microscopy was performed. If a clinical urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

    Measured: Day 1 through Day 14

  9. Frequency of Abnormal Changes in Electrocardiographic (ECG) Results

    Changes in ECG intervals and morphological changes from baseline up to 24 hours after dosing. The graded ECG measurements include PR interval and QTcF interval.

    Measured: 0 h through 24 h post dose

  10. Frequency of Audiology TEAEs

    TEAEs related to auditory (cochlear) function tests (pure-tone audiometry and distortion product otoacoustic emissions [DPOAEs]) through Day 30.

    Measured: Day 1 through Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start16 Jun 2023
  3. Primary completion22 Oct 2023
  4. Study completion22 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590728
Sponsor's protocol ID
20-0012
Status last verified
17 Oct 2022
First submitted
21 Jul 2022
Last updated
6 Mar 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apramycin (EBL-1003) in people with Bacterial Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time Zero to 8 h (AUC 0-8) of Total Apramycin in Epithelial Lining Fluid (ELF) and Alveolar Macrophage (AM) (time frame: 0 h through 8 h post dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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