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Aminoglycoside Antibiotic
Apramycin for Bacterial Infection
Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 30
Awards & highlights
Study Summary
This trial studies the safety & effectiveness of a single dose of medicine administered intravenously in 20 healthy people. Blood & lung samples are taken to assess the medicine's pharmacokinetics & penetration.
Who is the study for?
Healthy adults aged 18-45, with a BMI of 18.0 to 32.0 and weight over 50 kg can join this trial. They must have normal hearing, lung function, and no history of significant allergies or chronic diseases that could affect the study results. Women who can get pregnant must use effective birth control.Check my eligibility
What is being tested?
The trial is testing Apramycin (EBL-1003), an antibiotic given through IV for bacterial infections. Participants are divided into groups to receive the drug at different times and then undergo a bronchoscopy with BAL to measure how much drug gets into the lungs.See study design
What are the potential side effects?
Possible side effects aren't detailed in the provided information but may include reactions related to IV administration, changes in hearing or balance due to apramycin's properties as an aminoglycoside antibiotic, and potential impact on kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lung
Area under the concentration time-curve from time zero to 24 h of total apramycin in plasma.
Area under the concentration time-curve from time zero to infinity of total apramycin in plasma.
+12 moreSecondary outcome measures
Frequency of changes in electrocardiographic (ECG) intervals
Frequency of clinically significant Treatment-emergent adverse events (TEAEs) in Physical examination (PE) findings
Incidence of serious adverse events (SAEs)
+2 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: T5Experimental Treatment1 Intervention
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
Group II: T4Experimental Treatment1 Intervention
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
Group III: T3Experimental Treatment1 Intervention
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
Group IV: T2Experimental Treatment1 Intervention
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
Group V: T1Experimental Treatment1 Intervention
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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,217 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are planning to participate in another research study that requires treatment with medication or blood draws during the same time as this study.You have had problems with your hearing and/or balance within the past 2 years.You should avoid loud noises by not using earpieces at high volume or attending loud events like concerts, dances, or fireworks.You have a long-term health condition that may increase the risk of participating in the trial or affect the study results.You have had surgery or injury to your middle or inner ears in the past.If you had surgery to insert tubes in your ears when you were younger, but your hearing has returned to normal and your eardrum has fully healed, you can participate.You can continue taking birth control pills during the study, and you can take a one-time dose of up to 1,000 mg of paracetamol (a pain reliever).You are not allowed to take certain medications like benzodiazepines or topical anesthetics, including drugs like lidocaine or xylocaine.Your ears are healthy, and your eardrums move normally when tested.Nicotine products such as cigarettes, e-cigarettes, chewing tobacco, and nicotine patches are not allowed.You have not had a respiratory infection in the four weeks before the screening.Your family has a history of hearing loss before age 60.You cannot have any food or drinks with caffeine 2 days before the trial until day 3 of the trial. After that, you can only have up to 3 cups or equivalent of caffeine per day during the follow-up period.You regularly drink more than 1-2 drinks per day (for women and men respectively) or have a history of alcohol or drug abuse. You may also be excluded if there is suspicion or evidence of current drug use.You have certain conditions that affect your ears, such as hearing aids, head injuries, tumors, autoimmune diseases, or certain types of hearing loss.
Research Study Groups:
This trial has the following groups:- Group 1: T5
- Group 2: T1
- Group 3: T2
- Group 4: T3
- Group 5: T4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age requirement to be involved in this experiment?
"Participants eligible for this experiment must meet the age criteria of being at least 18, yet younger than 45."
Answered by AI
Has T3 received formal sanction from the FDA?
"T3's safety was judged to be a 1 on our scale due to the minimal data available from this Phase 1 trial, which indicates limited understanding of both efficacy and safety."
Answered by AI
What are the eligibility criteria for participation in this trial?
"The current clinical trial is seeking 20 participants of both sexes, aged 18-45 years old, who are diagnosed with a bacterial infection. In order to participate in the study, subjects must read and endorse an ICF (Informed Consent Form), have no pre-existing conditions that could influence outcomes as determined by medical history review/physical examination/vital signs/clinical laboratory tests/12-lead ECG within reference ranges at Screening & Day 2; accept measurements for HR & BP w/ subject resting between readings 5+ minutes if needed; be non-pregnant women using highly effective contraceptive methods or postmenopausal; and"
Answered by AI
Is the research program presently recruiting participants?
"According to the clinicaltrials.gov, this study is no longer enrolling participants. The original posting date was September 1st 2023 and it last updated on November 23rd 2022. However, there are still 62 other medical trials open for enrollment at present."
Answered by AI
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