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Bacterial InfectionPhase 1NCT03910673

Intravenous Fosfomycin Pharmacokinetics Study

A Phase 1 study testing Fosfomycin disodium in people with Bacterial Infection and Multiple-drug Resistance, 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
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Fosfomycin disodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
27 Jun 2019to 17 Dec 2020
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

  • Healthy* men and women aged 18-45 years with no clinically significant findings** at Screening and Baseline (Day -1 to Day 1)
  • Healthy is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal physical exam including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: 1) first diagnosed within 3 months of enrollment; 2) is worsening in terms of clinical outcome in the last 6 months; or 3) involves need for medication.
  • Including findings on medical history, physical exam, vital signs, 12-lead Electrocardiogram (ECG), or clinical laboratory tests.
  • Body Mass Index (BMI) = 18 - 30 kg / m^2, inclusive, and body weight > 50 kg (110 lbs).
  • Females who have been surgically sterilized via bilateral oophorectomy and/or hysterectomy at least 90 days prior to Screening are considered lacking childbearing potential and will be eligible*.
  • Postmenopausal females are not eligible, as the definition of menopause would require age > 45, and all subjects in this study are age < / = 45.
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  • Females of childbearing potential must have a negative serum pregnancy test at Screening, a negative urine pregnancy test at Baseline (Day -1 to Day 1), and must use acceptable contraception*.
  • Acceptable contraception methods are restricted to surgical sterilization (bilateral tubal ligation) or successful Essure placement (permanent, non-surgical, non-hormonal sterilization with documented radiological confirmation at least 90 days after the procedure), use of long-acting reversible contraceptive devices (progestin-releasing subdermal implants [Nexplanon and Implanon, Merck], copper intrauterine devices [Paragard, Teva], and levonorgestrel-releasing intrauterine devices [Mirena, Bayer; Skyla, Bayer; Liletta, Allergan/Medicines360]), licensed hormonal products such as injectables or oral contraceptives, barrier methods such as condoms or diaphragms with spermicidal agents, and abstinence from sexual intercourse with a male partner. Subjects must have used the above-listed method for a minimum of 30 days prior to the first dose of study drug and be willing to use the method for at least 30 days after the final dose of study drug.
  • Male subjects* whose partners are of childbearing age or pregnant must be willing to use condoms during the study and through the Day 3 follow-up call.
  • including men who have had vasectomies
  • Able to abstain from alcoholic beverages within 48 hours before Baseline (Day -1 to Day 1) and throughout the Treatment Phase.
  • Able to abstain from caffeine use within 7 days before Baseline (Day -1 to Day 1) and throughout the inpatient period.
  • Willing to remain in Duke Early Phase Research Unit (DEPRU) during the Baseline and Treatment Phases.
  • Have a high probability for compliance and completion of the trial.
  • Sign a dated, witnessed, written Informed Consent Form (ICF).
  • Have adequate venous access for infusions and blood draws.

Who cannot join

  • Any surgical or medical condition that in the opinion of the investigator could interfere with drug absorption, distribution, metabolism, or excretion.
  • Any surgical or medical condition that in the opinion of the investigator may place the subject at increased risk while participating in the trial.
  • History or presence of cardiovascular disease including coronary artery disease and chronic hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg).
  • Abnormal Electrocardiogram (ECG) at screening, as determined by the investigator to be clinically significant.
  • History or presence of renal impairment or chronic renal disease.
  • History or presence of liver disease (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or total bilirubin above the upper limit of normal).
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  • History or presence of chronic pulmonary disease, including asthma, requiring use of medication in the year before screening.
  • History of intolerance or hypersensitivity to phosphonic acid derivative antibiotics or any of its constituents (i.e., oral or intravenous fosfomycin).
  • Have cancer or have a history of cancer within the past 5 years, with the exception of non-melanomatous skin cancer, treated, without evidence of recurrence.
  • Any medical condition that prevents a subject from undergoing bronchoscopy with bronchoalveolar lavage (BAL).
  • Serum creatinine above the upper limit of normal, or estimated creatinine clearance (CrCl) < 60 mL / min as determined by Cockcroft-Gault equation*.
  • Cockcroft-Gault equation where age is in years, weight is in kilograms, and serum Cr is in mg/dL units: Males: CrCl (mL / min) = (140 - age) x Weight / (72 x Cr) Females: CrCl (mL / min) = [(140 - age) x Weight / (72 x Cr)] x 0.85
  • History of regular alcohol consumption within 6 months of Baseline (Day -1 to Day 1)*.
  • History of regular alcohol consumption is defined as an average weekly intake of > 14 drinks for males or > 7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine, or 1.5 ounces (45 mL) of 80 proof distilled spirits.
  • History of > / = 10 pack-years smoking, or history of any nicotine use* in the 6 months before Baseline (Day -1 to Day 1)** or positive urinine cotinine screen at Basline (Day -1 to Day 1).
  • Including cigarettes, pipe, cigar, chewing tobacco, nicotine patch.
  • A positive urine cotinine at screening is allowed if negative at baseline.
  • History of illicit drug use within 6 months of Baseline (Day -1 to Day 1)*.
  • Use of cannabinoids within 1 month of Baseline (Day -1 to Day 1) is excluded, but other use of cannabinoids within 6 months is permitted.
  • Use of any prescription drugs, except acceptable contraception methods listed above, within 30 days of Baseline (Day -1 to Day 1).
  • Involvement in other investigational studies of any type (drugs, devices, procedures) within 30 days of Baseline (Day -1 to Day 1).
  • Blood or blood products donation within 30 days of Baseline (Day -1 to Day 1).
  • Planning egg or sperm donation any time before Day 3 follow-up call.
  • Use of any non-prescription medications, vitamins, consumption > 2 times/week of products containing genuine licorice, caffeine, or dietary or herbal supplements within 7 days of Baseline (Day -1 to Day 1)*.
  • Excluded from this list is intermittent use of acetaminophen at doses < / = 2 g / day. Herbal supplements must be discontinued 7 days before the initial dose of study drug on Day 1.
  • Presence of any acute illness, including febrile illness with temperature > 37.8 degrees Celsius (> 100.0 degrees Fahrenheit), within 7 days of Baseline (Day -1 to Day 1).
  • Currently pregnant or breastfeeding as determined by subject report.
  • Positive tests for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.
  • Positive urine drug or positive breathalyzer test for alcohol at Screening or Baseline (Day -1 to Day 1) or positive cotinine at Baseline (Day -1 to Day 1).
  • Weight loss or gain of > 10% within 30 days of Baseline (Day -1 to Day 1).
  • Any laboratory value at screening or enrollment that is Grade 2 or more. A laboratory value that is Grade 1 will be allowed if not considered to be clinically significant by the investigator*.
  • Excluded from this list of permissible Grade 1 laboratory values are (ALT), (AST), or Total bilirubin per Exclusion Criteria 6 and serum creatinine per Exclusion Criteria #11; and serum electrolytes including sodium, potassium, calcium, phosphorus and magnesium.
  • History of infection with SARS-CoV-2 (COVID-19) within 3 months of Baseline (Day -1 to Day 1) or unresolved symptoms of COVID-19.
  • Positive test for SARS-CoV-2 (COVID-19) at Screening or Baseline (Day -1 to Day 1) within 72 hours of admission

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Human Vaccine Institute - Duke Vaccine and Trials Unit

    Durham, North Carolina, 27704

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Fosfomycin disodium
Keywords
Adults, Fosfomycin Disodium, Healthy, Intrapulmonary, Intravenous, Pharmacokinetics, Phase 1, ZTI-01
Medical subject headings
Bacterial Infections

What participants receive

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

  • Fosfomycin disodiumDrug

    Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt.

Study groups in NCT03910673
Study groupRoleWhat they receive
2-Hour GroupExperimentalZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 2 hours after start of third infusion dose. n = 6
Receives: Drug: Fosfomycin disodium
30-Minute GroupExperimentalZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 30 minutes after start of third infusion dose. n = 6
Receives: Drug: Fosfomycin disodium
5-Hour GroupExperimentalZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 5 hours after start of third infusion dose. n = 6
Receives: Drug: Fosfomycin disodium
75-Minute GroupExperimentalZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 75 minutes after start of third infusion dose. n = 6
Receives: Drug: Fosfomycin disodium
8-Hour GroupExperimentalZTI-01 administered as 1-hour IV infusions (+10 minute window) given every 8 hours for three doses. Each dose comprised of 200 mL (6 g) of fosfomycin disodium. Bronchoscopy and bronchoalveolar lavage (BAL) performed 8 hours after start of third infusion dose. n = 6
Receives: Drug: Fosfomycin disodium

What is being measured

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

  1. Area Under the Concentration-time Curve (AUC 0-8 and AUC 0-inf ) of ZTI-01

    Mean and standard deviation (SD) of the AUC 0-8 (h*ug/mL) and AUC 0-inf (h*ug/mL). PK parameters were estimated from the ZTI-01 plasma concentration-time data after Dose 1 (Day 1) and Dose 3 (Day 2) using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for the plasma samples collected during the study. AUC 0-8 was estimated for the plasma concentration data after Dose 1 and Dose 3. AUC 0-inf was estimated for the plasma concentration data after Dose 3 with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 1.5 half-lives, and includes at least 3 timepoints after time to maximum concentration (tmax).

    Measured: Day 1 to Day 2

  2. Clearance (CL) of ZTI-01

    Mean and SD of the clearance (CL) of ZTI-01 (L/h). The clearance PK parameter was estimated from the ZTI-01 plasma concentration-time data after Dose 3 using Phoenix WinNonlin Non-compartmental analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 1.5 half-lives, and includes at least 3 timepoints after time to maximum concentration (tmax). Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for plasma samples collected during the study. If the amount extrapolated portion of AUC 0-inf was >20%, the estimated CL value was excluded from statistical summaries of the parameter estimates.

    Measured: Day 2

  3. Intrapulmonary Pharmacokinetics of ZTI-01

    Intrapulmonary pharmacokinetics of ZTI-01 was defined as the percent penetration of lung epithelial lining fluid (ELF) and alveolar macrophages (AMs). The estimate of the percent lung penetration was calculated by dividing the AUC 0-8 of ELF and AM by the AUC 0-8 of plasma fosfomycin. The AUC 0-8 of ELF and AM was calculated using the median result at each BAL sampling timepoint, resulting in a single AUC 0-8 of ELF and AM across all subjects. The AUC 0-8 of plasma fosfomycin was calculated using the median result of the plasma fosfomycin concentrations at the corresponding BAL timepoint.

    Measured: Day 2

  4. Maximum Measured Plasma Concentration (Cmax) of ZTI-01

    Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter were estimated from the ZTI-01 plasma concentration-time data after Dose 1 and Dose 3 using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for the plasma samples collected during the study.

    Measured: Day 1 to Day 2

  5. Number of Participants Experiencing Abnormal Clinical Chemistry Laboratory Assessments

    Each subject is only counted once per toxicity grade for the worst severity recorded. Clinical chemistry assessments with toxicity grading and associated thresholds include sodium <135 mEq/L or >145 mEq/L, potassium <3.5 mEq/L or >5.0 mEq/L, random glucose <=69 mg/dL or >=141 mg/dL, blood urea nitrogen (BUN) >=21 mg/dL, creatinine >1.0 mg/dL (Females) or >1.3 mg/dL (Males), calcium <8.7 mg/dL or >10.2 mg/dL, magnesium <=1.7 mg/dL, phosphorous <=2.2 mg/dL, creatine phosphokinase (CPK) >=221 mg/dL, albumin >=2.8 g/dL, total protein <5.8 g/dL, alkaline phosphatase (ALP) >=111 U/L, aspartate aminotransferase (AST) >=42 U/L, alanine aminotransferase (ALT) >54 U/L (Females) or >63 (Males) U/L, total bilirubin >=1.6 mg/dL, direct bilirubin >=0.7 mg/dL, total cholesterol >=301 mg/dL, triglycerides >500 mg/dL, and lactate dehydrogenase (LDH) >200 U/L.

    Measured: Day 1 to Day 2

  6. Number of Participants Experiencing Abnormal Clinical Hematology Laboratory Assessments

    Each subject is only counted once per toxicity grade for the worst severity recorded. Clinical hematology assessments with toxicity grading and associated threshold include hemoglobin <=11.9 g/dL (Females) or <= 13.6 g/dL (Males), white blood cell count <=3.1 10^9/L or >=9.9 10^9/L, lymphocytes <0.6 10^9/L, neutrophils <2.0 10^9/L, eosinophils >0.7 10^9/L, and platelets <=149 10^9/L.

    Measured: Day 1 to Day 2

  7. Number of Participants Experiencing Abnormal Clinical Coagulation Laboratory Assessments

    Each subject is only counted once per toxicity grade for the worst severity recorded. Clinical coagulation assessments with toxicity grading and associated threshold include prothrombin time (PT) >13.1 seconds and activated partial thromboplastic time (aPTT) >37.1 seconds.

    Measured: Day 1 to Day 2

  8. Number of Participants Experiencing Abnormal Clinical Urinalysis Laboratory Assessments

    Each subject is only counted once per toxicity grade for the worst severity recorded. Clinical urinalysis assessments with toxicity grading and associated threshold include protein >= 1+, glucose >= 1+, and red blood cell (RBC) count from microscopy >= 5 rbc/hpf.

    Measured: Day 1 to Day 2

  9. Number of Participants Experiencing Abnormal Physical Examination Findings

    Physical exams included 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).

    Measured: Day 1 to Day 2

  10. Number of Participants Experiencing Abnormal Vital Sign Measurements

    Each subject is only counted once per toxicity grade for the worst severity recorded. Vital sign measurements with toxicity grading and associated threshold include systolic blood pressure (BP) >=141 mmHg or <=89 mmHg; diastolic BP >=91 mmHg; heart rate >=101 beats per minute (bpm) and >25% change from baseline or <=54 bpm (if baseline >=60 bpm) or <=49 bpm (if baseline <60 bpm); respiratory rate >=23 breaths per minute; and temperature >=38.0 degrees Celsius.

    Measured: Day 1 to Day 2

  11. Number of Participants Experiencing Adverse Events (AEs)

    The number of participants who experienced at least one unsolicited treatment emergent AE (TEAE) of any severity and relatedness by MedDRA System Organ Class (SOC). AEs included local and systemic reactions. Any medical condition that was present at screening was considered as a baseline finding and not reported as an AE. However, if its Grade increased at any time during the trial such that it met the AE definition, it was recorded as an AE.

    Measured: Day 1 to Day 3

  12. Number of Participants With Prolonged QTc, PR, or QRS Intervals in Electrocardiogram (ECG) Readings

    Each subject is only counted once per toxicity grade for the worst severity recorded. ECG assessments with toxicity grading and associated threshold include QTc Interval >=450 msec, PR Interval >=200 msec and >25% change from baseline, and QRS Interval >=120 msec and >25% change from baseline.

    Measured: Day 1 to Day 2

  13. Terminal Elimination Half-life (t1/2) of ZTI-01

    Mean and standard deviation (SD) of the t1/2 (h) PK parameter were estimated from the ZTI-01 plasma concentration-time data after Dose 3 using Phoenix WinNonlin Non-compartmental analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 1.5 half-lives, and includes at least 3 timepoints after time to maximum concentration (tmax). Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for the plasma samples collected during the study.

    Measured: Day 2

  14. Terminal-phase Elimination Rate Constant (Lambdaz) of ZTI-01

    Mean and standard deviation (SD) of the lambdaz (/h) PK parameter were estimated from the ZTI-01 plasma concentration-time data after Dose 3 using Phoenix WinNonlin Non-compartmental analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 1.5 half-lives, and includes at least 3 timepoints after time to maximum concentration (tmax). Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for the plasma samples collected during the study.

    Measured: Day 2

  15. Time to Peak Concentration (Tmax) of ZTI-01

    Mean and standard deviation (SD) of the Tmax (h) PK parameter were estimated from the ZTI-01 plasma concentration-time data after Dose 1 and Dose 3 using Phoenix WinNonlin Non-compartmental analysis. Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for the plasma samples collected during the study.

    Measured: Day 1 to Day 2

  16. Volume of Distribution at Steady State (Vss) of ZTI-01

    Mean and standard deviation (SD) of the Vss (L) PK parameter were estimated from the ZTI-01 plasma concentration-time data after Dose 3 using Phoenix WinNonlin Non-compartmental analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 1.5 half-lives, and includes at least 3 timepoints after time to maximum concentration (tmax). Plasma concentrations were measured by a validated LC-MS/MS bioanalytical assay for plasma samples collected during the study. If the amount extrapolated portion of AUC 0-inf was >20%, the estimated Vss value was excluded from statistical summaries of the parameter estimates.

    Measured: Day 2

Timeline

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

  1. First posted10 Apr 2019
  2. Study start27 Jun 2019
  3. Primary completion17 Dec 2020
  4. Study completion17 Dec 2020

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03910673
Sponsor's protocol ID
16-0058
Other IDs
HHSN272201300017I
Status last verified
13 Mar 2020
First submitted
28 Mar 2019
Last updated
23 Oct 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Boole L, Yang Z, Bergin SP, Tighe RM, Randolph E, Hauser B, Gu K, Ghazaryan V, Wall A, Weigand K, Walter EB, Que LG. Evaluation of the safety profile and intrapulmonary pharmacokinetics of intravenous fosfomycin in healthy adults. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0139524. doi: 10.1128/aac.01395-24. Epub 2025 Jan 8.

    PubMed 39772650

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fosfomycin disodium in people with Bacterial Infection and Multiple-drug Resistance, 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 16 inclusion and 34 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 23 Oct 2023. 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 19 Jan 2022). 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 (AUC 0-8 and AUC 0-inf ) of ZTI-01 (time frame: Day 1 to Day 2). The study lists 16 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 NCT03910673, which also lists 1 linked publication.

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 23 Oct 2023.

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