CClinicalTrials.gg
Sign In
CompletedNCT05590728Updated Mar 6, 2025Results posted

Safety of Intravenous Apramycin in Adults

A Phase 1 interventional study of Apramycin (EBL-1003) in Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bacterial Infection

Browse trials for

Keywords

  • Apramycin
  • Lung Pharmacokinetics
  • Open-label
  • Phase I
  • Respiratory
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 16 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.

  2. 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.
    • 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.

  3. 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.

  4. 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.

  5. BMI 18.0 to 32.0 kg/m\^2 (inclusive) and body weight not less than 50 kg.
  6. 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.

  7. 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.

  8. Normal otoscopic findings in the ears, normal tympanic membrane mobility and stapedial reflex present.

  9. 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.

  10. Normal lung function with Forced Expiratory Volume in the first second (FEV1) predicted >/= 80% and FEV1/Forced Vital Capacity (FVC) > 70%.
  11. 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).
  12. No history of acute febrile or infectious illness for at least 7 days prior to the administration of the IMP.
  13. No history of lower respiratory tract infection within 4 weeks prior to screening.
  14. Have adequate venous access for infusion and blood draws.

Exclusion criteria

Exclusion Criteria:

All must be answered NO for the subject to be eligible for study participation:

  1. Lactating females.

    Medical and surgical history:

  2. Any history of hypersensitivity to aminoglycosides.
  3. Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis.
  4. 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.

  5. 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.
  6. History of any psychiatric medical condition that has required hospitalization in the last 5 years or subject is considered psychologically unstable by the investigator.

  7. 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.

  8. 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.

  9. Family history of hearing loss before the age of 60.

  10. 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:

  11. Positive serum pregnancy test for women at screening or urine pregnancy test at check-in.

  12. Positive test for HIV antibodies, hepatitis B-virus surface antigen (HBsAg), or anti-hepatitis C-virus antibodies (anti-HCV).

    Prior medication:

  13. 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.

  14. Use of any investigational drug product within 30 days or 5 half-lives (whichever is longer) before dosing.

  15. 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:

  16. 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.
  17. Any history of alcohol or drug abuse or positive alcohol breathalyzer test.
  18. Suspicion of illicit drug use / abuse or positive urine drug screen test.

  19. 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).
  20. 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.
  21. Judged by the investigator to have occupational noise exposure of high risk during the trial (e.g., construction site workers, military workers, etc.).
  22. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    T1

    Subjects 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

    Drug: Apramycin (EBL-1003)

  • Experimental
    T2

    Subjects 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

    Drug: Apramycin (EBL-1003)

  • Experimental
    T3

    Subjects 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

    Drug: Apramycin (EBL-1003)

  • Experimental
    T4

    Subjects 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

    Drug: Apramycin (EBL-1003)

  • Experimental
    T5

    Subjects 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

    Drug: Apramycin (EBL-1003)

Interventions

  • DrugApramycin (EBL-1003)

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 0 h through 8 h post dose

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Day 1 through Day 30

07

Results

Posted Dec 10, 2024

Participant flow

The study population included healthy male and female adults, ages 18-45 years, inclusive, who met all eligibility criteria. Participants were enrolled between May 15, 2023 and October 16, 2023 and were recruited from the community at large.

Participant flow — Overall Study
Milestone30 Minute BAL2 Hour BAL4 Hour BAL8 Hour BAL24 Hour BAL
Started44440
Started infusion44440
Completed infusion44440
Completed bronchoscopy with bal44440
Completed all pk blood draws34440
Completed all plasma urea blood draws34440
Completed44440
Not completed00000

Outcome measures

PrimaryArea 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.

Time frame:
0 h through 8 h post dose
Reported as:
Number · ug*h/mL
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)
ug*h/mLApramycin All Participants
ELF142.8
AM131.7
PrimaryArea 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.

Time frame:
0 h through 8 h post dose
Reported as:
Number · ug*h/mL
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of Total Apramycin in ELF and AM
ug*h/mLApramycin All Participants
ELF197.3
AMNA
PrimaryMaximum 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.

Time frame:
0 h though 8 h post dose
Reported as:
Number · ug/mL
Maximum Concentration (Cmax) of Total Apramycin in ELF and AM
ug/mLApramycin All Participants
ELF27.47
AM42.37
PrimaryTime 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.

Time frame:
0 h through 8 h post dose
Reported as:
Number · h
Time of Maximum Concentration (Tmax) of Total Apramycin in ELF and AM
hApramycin All Participants
ELF0.5
AM8
PrimaryTerminal 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.

Time frame:
0 h through 8 h post dose
Reported as:
Number · h
Terminal Elimination Half-Life (t1/2) of Total Apramycin in ELF and AM
hApramycin All Participants
ELF4.05
AMNA
PrimaryArea 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.

Time frame:
0 h through 8 h post dose
Reported as:
Geometric mean · ug*h/mL
Area Under the Concentration-time Curve From Time Zero to 8 h (AUC 0-8) of Total Apramycin in Plasma
ug*h/mLApramycin All Participants
Area Under the Concentration-time Curve From Time Zero to 8 h (AUC 0-8) of Total Apramycin in Plasma443.9 ± 11
PrimaryArea 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.

Time frame:
0 h through 24 h post dose
Reported as:
Geometric mean · ug*h/mL
Area Under the Concentration-time Curve From Time Zero to 24 h (AUC 0-24) of Total Apramycin in Plasma
ug*h/mLApramycin All Participants
Area Under the Concentration-time Curve From Time Zero to 24 h (AUC 0-24) of Total Apramycin in Plasma486.7 ± 13
PrimaryArea 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.

Time frame:
0 h through 60 h post dose
Reported as:
Geometric mean · ug*h/mL
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
ug*h/mLApramycin All Participants
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 Plasma490.3 ± 13
PrimaryArea 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).

Time frame:
0 h through 60 h post dose
Reported as:
Geometric mean · ug*h/mL
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of Total Apramycin in Plasma
ug*h/mLApramycin All Participants
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of Total Apramycin in Plasma500.3 ± 14
PrimaryMaximum 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.

Time frame:
0 h though 60 h post dose
Reported as:
Geometric mean · ug/mL
Maximum Concentration (Cmax) of Total Apramycin in Plasma
ug/mLApramycin All Participants
Maximum Concentration (Cmax) of Total Apramycin in Plasma172.1 ± 10
PrimaryTime 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.

Time frame:
0 h through 60 h post dose
Reported as:
Geometric mean · h
Time of Maximum Concentration (Tmax) of Total Apramycin in Plasma
hApramycin All Participants
Time of Maximum Concentration (Tmax) of Total Apramycin in Plasma0.595 ± 32
PrimaryTerminal 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).

Time frame:
0 h through 60 h post dose
Reported as:
Geometric mean · h
Terminal Elimination Half-Life (t1/2) of Total Apramycin in Plasma
hApramycin All Participants
Terminal Elimination Half-Life (t1/2) of Total Apramycin in Plasma19.1 ± 19
PrimaryCentral 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).

Time frame:
0 h to 60 h post dose
Reported as:
Geometric mean · L/kg
Central Volume of Distribution (Vd) of Total Apramycin in Plasma
L/kgApramycin All Participants
Central Volume of Distribution (Vd) of Total Apramycin in Plasma1.64 ± 22
PrimaryTotal 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).

Time frame:
0 h through 60 h post dose
Reported as:
Geometric mean · L/h/kg
Total Clearance (CLT) of Total Apramycin in Plasma
L/h/kgApramycin All Participants
Total Clearance (CLT) of Total Apramycin in Plasma0.0600 ± 14
PrimaryRatio 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.

Time frame:
0 h through 8 h post dose
Reported as:
Number · ratio of lung PK to plasma PK
Ratio of ELF to Plasma and AM to Plasma Apramycin Exposure Parameters
ratio of lung PK to plasma PKApramycin All Participants
Cmax, ELF to Plasma0.144
Cmax, AM to Plasma0.222
AUC 0-8, ELF to Plasma0.324
AUC 0-8, AM to Plasma0.299
AUC 0-inf, ELF to Plasma0.404
AUC 0-inf, AM to PlasmaNA
SecondaryFrequency 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.

Time frame:
Day 1 through Day 30
Reported as:
Count of participants · Participants
Frequency of Serious Adverse Events (SAEs)
ParticipantsApramycin All Participants
Frequency of Serious Adverse Events (SAEs)0
SecondaryFrequency 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.

Time frame:
Day 1 through Day 30
Reported as:
Count of participants · Participants
Frequency of Treatment-emergent Adverse Events (TEAEs)
ParticipantsApramycin All Participants
Ear and labyrinth disorders4
Eye disorders1
General disorders and administration site conditions1
Infections and infestations1
Injury, poisoning and procedural complications1
Investigations5
Nervous system disorders1
Respiratory, thoracic and mediastinal disorders2
SecondaryFrequency 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.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Frequency of Abnormal Physical Exam Findings
ParticipantsApramycin All Participants
Head, Eyes, Ears, Nose, Throat (HEENT)2
Musculoskeletal1
SecondaryFrequency 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.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Frequency of Abnormal Vital Sign Findings
ParticipantsApramycin All Participants
Systolic blood pressure - decrease1
Systolic blood pressure - increase0
Diastolic blood pressure - decrease0
Diastolic blood pressure - increase0
Pulse - decrease2
Pulse - increase0
Respiratory rate - decrease0
Respiratory rate - increase0
Oral temperature - decrease0
Oral temperature - increase5
SecondaryFrequency 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.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Frequency of Abnormal Chemistry Lab Measurements
ParticipantsApramycin All Participants
Sodium - decrease0
Sodium - increase0
Potassium - decrease0
Potassium - increase0
Glucose - decrease0
Glucose - increase2
Blood urea nitrogen - increase0
Creatinine - increase0
Calcium - decrease0
Calcium - increase1
Magnesium - decrease0
Carbon dioxide - decrease0
Carbon dioxide - increase3
Albumin - decrease1
Total protein - decrease0
Alkaline phosphatase - increase0
Alanine aminotransferase - increase0
Aspartate aminotransferase - increase0
Total bilirubin - increase1
Direct bilirubin - increase0
SecondaryFrequency 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.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Frequency of Abnormal Hematology Lab Measurements
ParticipantsApramycin All Participants
Hemoglobin - decrease0
Platelets - decrease0
White blood cells - decrease2
White blood cells - increase2
Neutrophils - decrease0
Lymphocytes - decrease0
Eosinophils - increase1
Basophils - increase0
Monocytes - increase1
SecondaryFrequency 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.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Frequency of Abnormal Coagulation Lab Measurements
ParticipantsApramycin All Participants
Activated partial thromboplastin time - increase3
Prothrombin time - increase2
Prothrombin international normalized ratio - increase2
SecondaryFrequency 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.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Frequency of Abnormal Urinalysis Lab Measurements
ParticipantsApramycin All Participants
Protein by dipstick - increase2
Glucose by dipstick - increase0
Blood by dipstick - increase4
White blood cells by microscopy - increase0
Red blood cells by microscopy - increase1
Bacteria by microscopy - increase1
SecondaryFrequency 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.

Time frame:
0 h through 24 h post dose
Reported as:
Count of participants · Participants
Frequency of Abnormal Changes in Electrocardiographic (ECG) Results
ParticipantsApramycin All Participants
PR interval0
QTcF interval0
SecondaryFrequency of Audiology TEAEs

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

Time frame:
Day 1 through Day 30
Reported as:
Count of participants · Participants
Frequency of Audiology TEAEs
ParticipantsApramycin All Participants
Frequency of Audiology TEAEs4

Adverse events

Collected over All treatment emergent adverse events (TEAEs) were documented from time of study drug dosing through the time of last assessment (e.g., Day 14 +/- 3 days of clinical safety labs and ECGs) or Final Visit (Day 30 +/- 4 days).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Apramycin All Participants0/16 (0%)0/16 (0%)15/16 (93.8%)
Most frequent other events
Showing 10 of 31
Most frequent other events
EventApramycin All Participants
HypoacusisEar and labyrinth disorders4/16
Blood urine presentInvestigations4/16
Body temperature increasedInvestigations3/16
Activated partial thromboplastin time prolongedInvestigations3/16
Carbon dioxide increasedInvestigations3/16
Heart rate decreasedInvestigations2/16
Blood glucose increasedInvestigations2/16
International normalised ratio increasedInvestigations2/16
Protein urine presentInvestigations2/16
Prothrombin time prolongedInvestigations2/16

Baseline characteristics

The safety population includes all participants who received any amount of apramycin.

Age, Continuous
Age, Continuous(years)30 Minute BAL2 Hour BAL4 Hour BAL8 Hour BALTotal
Mean31.3 ± 10.034.0 ± 3.527.0 ± 6.230.5 ± 8.830.7 ± 7.2
Sex: Female, Male
Sex: Female, Male(Participants)30 Minute BAL2 Hour BAL4 Hour BAL8 Hour BALTotal
Female21148
Male23308
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)30 Minute BAL2 Hour BAL4 Hour BAL8 Hour BALTotal
Hispanic or Latino20013
Not Hispanic or Latino244313
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)30 Minute BAL2 Hour BAL4 Hour BAL8 Hour BALTotal
American Indian or Alaska Native00000
Asian00011
Native Hawaiian or Other Pacific Islander10001
Black or African American02204
White322310
More than one race00000
Unknown or Not Reported00000
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)30 Minute BAL2 Hour BAL4 Hour BAL8 Hour BALTotal
Mean28.13 ± 2.7027.08 ± 2.8424.50 ± 3.2826.78 ± 3.1026.62 ± 3.00
08

Study locations

1 site
  • Alliance for Multispecialty Research, LLC - Knoxville
    Knoxville, Tennessee 37920, United States
09

References and documents

Study documents

  • Study protocol · Jul 10, 2023
  • Statistical analysis plan · Feb 7, 2023
  • Informed consent form · May 6, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05590728
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Oct 21, 2022
Start date
Jun 16, 2023
Primary completion
Oct 22, 2023
Completion
Oct 22, 2023
Results posted
Dec 10, 2024
Last update
Mar 6, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Bacterial Infections→

Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Start the discussion