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NCT05590728 · ClinicalTrials.gov registry record · Phase 1
Safety of Intravenous Apramycin in Adults
A Phase 1 study of Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05590728: Completed Phase 1 study of Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05590728 is a Phase 1 study of Bacterial Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 16 participants, below the 103-participant average among 8 other Bacterial Infection trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05590728, a Phase 1 study of Bacterial Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Apramycin (EBL-1003)
Study Locations (1)
Tennessee
- Alliance for Multispecialty Research, LLC - Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2023-10-22 |
| Phase | Phase 1 |
What the finished NCT05590728 record still lists
NCT05590728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 103-participant average among 8 other Bacterial Infection trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Bacterial Infection appearing as the primary indexed condition, and to 1 intervention - of which Apramycin (EBL-1003) is the first listed.
NCT05590728 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05590728 about?
NCT05590728 is a clinical study titled "Safety of Intravenous Apramycin in Adults". 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 broncho...
What is the current status of trial NCT05590728?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-06-16. Estimated completion is 2023-10-22.
What conditions does trial NCT05590728 study?
This clinical trial studies the following conditions: Bacterial Infection.
What interventions are being tested in trial NCT05590728?
The interventions under investigation include: Apramycin (EBL-1003) (DRUG).
Who is sponsoring clinical trial NCT05590728?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05590728 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05590728's enrollment target sits among peer trials
16 9th of 8 the lowest of 8 other Bacterial Infection trials
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