Covid 19 Clinical Trials

This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling timepoint, with blood sampling volume that is adequate for testing. The objectives of the study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of IV-infused ZTI-01.

NCT03910673 Bacterial Infection Multiple-drug Resistance Pathogen Resistance Drug: Fosfomycin disodium

MeSH:Bacterial Infections

Primary Outcomes

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Area under the concentration vs. time curve (AUC0-8 and AUC0-infinity) for ZTI -01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study

Measure: Clearance (CL) of ZTI-01

Time: Day 1 to Day 2

Description: Defined as percent penetration of lung epithelial lining fluid (ELF) and alveolar macrophages (AMs). The ratios of ELF and AM concentrations of fosfomycin to simultaneous plasma concentrations will be calculated for each subject and summarized for each sampling time. The median concentrations of fosfomycin from the BAL sampling times will be used to estimate the AUC0-8 of plasma, ELF, and AM. The ratio of AUC0-8 of ELF-to-plasma and AM-to-plasma will be calculated to determine the percent penetration.

Measure: Intrapulmonary pharmacokinetics of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Maximum measured plasma concentration (Cmax) of ZTI-01

Time: Day 1 to Day 2

Description: Clinical laboratory evaluations include serum chemistry (albumin, glucose, blood urea nitrogen (BUN), potassium, magnesium, calcium, sodium, total protein, creatinine, triglycerides, total cholesterol, creatine phosphokinase (CPK), phosphorus, alkaline phosphatase (ALP), AST, ALT, total bilirubin, direct bilirubin, and lactate dehydrogenase (LDH)), hematology (CBC with differential (hemoglobin, hematocrit, platelet count, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, basophils)), coagulation (PT and aPTT), urinalysis (leukocyte esterase, blood, pH, specific gravity, glucose, protein), and plasma urea concentration.

Measure: Number of participants experiencing abnormal clinical laboratory assessments compared to baseline

Time: Day 1 to Day 2

Description: Physical exams will include assessment of skin, head and neck, lungs, heart, liver, spleen, extremities, lymph nodes, musculoskeletal system/extremities, abdomen, nervous system, weight, height, and body mass index (BMI).

Measure: Number of participants experiencing abnormal physical examination findings compared to baseline

Time: Day 1 to Day 2

Description: Vital sign measurements will include heart rate, blood pressure, temperature, respiratory rate, and peripheral oxygen saturation.

Measure: Number of participants experiencing abnormal vital sign measurements compared to baseline

Time: Day 1 to Day 2

Measure: Number of participants experiencing adverse events (AEs)

Time: Day 1 to Day 3

Description: QTc, PR, and QRS intervals are expressed in milliseconds (msec).

Measure: Number of participants with prolonged QTc, PR, or QRS interval in electrocardiogram (ECG) readings

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Terminal elimination half-life (t1/2) of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Terminal-phase elimination rate constant (lambdaz) of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Time to peak concentration (Tmax) of ZTI-01

Time: Day 1 to Day 2

Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.

Measure: Volume of ZTI-01 distribution (Vd)

Time: Day 1 to Day 2

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Fosfomycin disodiumWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (3)

Correlated MeSH Terms (1)

Correlated HPO Terms (0)

Clinical Trials

1 A Phase 1 Safety and Intrapulmonary Pharmacokinetics Study of ZTI-01 (Intravenous Fosfomycin Disodium) in Healthy Adult Subjects

NCT03910673 Bacterial Infection Multiple-drug Resistance Pathogen Resistance Drug: Fosfomycin disodium

MeSH:Bacterial Infections

Primary Outcomes

No related HPO nodes (Using clinical trials)