PharmacokineticsPhase 1BORANCT05148312
Single-dose AQ001S PK Study in Healthy Volunteers
A Phase 1 study testing Budesonide Inhalant Product in people with Pharmacokinetics, run by Aquilon Pharmaceuticals S.A. at 1 site in Bulgaria.
Trial summary
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Budesonide Inhalant Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBulgaria
- Study dates
- 12 Nov 2021to 21 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have given written informed consent.
- Healthy volunteers of both genders, aged ≥ 18 and ≤ 60 years.
- Subjects with body weight > 45 kg and Body Mass Index ≥ 18.5 and ≤ 24.9kg/m2.
- Healthy volunteers are declared healthy based on medical history, physical examination, electrocardiogram, pulmonary function test (Forced Expiratory Volume in 1 second ≥ 80% of the predicted normal value and Forced Expiratory Volume in 1 second/ Forced Vital Capacity ≥ 70%).
- Clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.
- Subjects who never smoked.
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- Women of childbearing potential (WOCBP) may be enrolled if they practice a method of birth control with a reliability of at least 90% and agree to continue doing so throughout the treatment period (e.g. condom, intrauterine device or hormonal contraception).
- Any female subject with childbearing potential has a negative pregnancy test at Screening visit and prior to dosing at each treatment period.
- Reliable subjects who are willing to be available for the duration of the clinical study and willing to comply with clinical study procedures.
- Subjects who have the ability to understand the requirements of the clinical study.
Who cannot join
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history) or clinically relevant laboratory abnormalities.
- Clinically significant history or presence of pulmonary malformations, chronic bronchitis, asthma, emphysema, cystic fibrosis or any other pulmonary disease
- History or presence of pulmonary tuberculosis.
- Viral or bacterial upper or lower respiratory tract infection, or sinus or middle ear infection, within 4 weeks prior to the screening visit.
- Untreated oral candidiasis.
- History or presence of prolonged QTc interval (> 450 ms), or any other clinically significant electrocardiogram abnormalities as judged by the Investigator based on 12-lead electrocardiogram recordings at Screening Visit.
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- History or presence of malignancy of any system organ class (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years prior to Screening Visit, regardless of whether there is no evidence of local recurrence or metastases.
- Eye disorders, especially glaucoma, or a family history of glaucoma.
- History of alcohol or drug abuse.
- Inability to abstain from alcohol consumption for the duration of study period.
- Immunosuppressive treatment, including topical and systemic corticosteroids (e.g., oral, parenteral, ocular, nasal or inhaled), within 4 weeks before Screening Visit.
- Use of prescription or non-prescription drugs, except for simple analgesics (e.g. paracetamol) and hormonal contraception for women, including vitamins, herbal and dietary supplements (including St John's Wort [Hypericum]) within 7 days (or 2 weeks if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the Screening Visit.
- Pregnant or breastfeeding female subjects.
- History of hypersensitivity or existing contraindication to budesonide or any other study medication ingredients.
- Blood or plasma donation within 4 weeks prior to Screening Visit.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the clinical study.
- History or presence of any other clinically relevant disease of any major system organ class (e.g. cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological including any type of Diabetes mellitus, neurological, psychiatric or orthopedic disease) as judged by the Investigator.
- COVID-19, Hepatitis B and C and HIV positive tests
- Any COVID-19 vaccine within 2 weeks prior to the first dose of study drugs, and during the entire study participation including 2 weeks after the last dose of study drug.
- Subjects who participated in an investigational study within the 12 weeks prior to the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single-center, Single-dose, Four-period Crossover Clinical Trial to Assess the PK Profile and Safety of Budesonide Inhalation Solution AQ001S Compared to Budesonide Inhalation Suspension in Healthy Volunteers
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.
Read the detailed description
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml.
Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization.
The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution.
The primary safety objective is to assess the safety of AQ001S inhalation solution.
- Conditions
- Pharmacokinetics
- Being tested
- Budesonide Inhalant Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide Inhalant ProductDrug
Also called Budesonide solution administered by nebulization
Single-dose of budesonide solution administered by nebulization.
| Study group | Role | What they receive |
|---|---|---|
| AQ001S 0.125 mg/2mL single-dose | Experimental | AQ001S 0.125 mg/2 ml (budesonide 0.125 mg/2 ml inhalation solution) single-dose administered by nebulization. Receives: Drug: Budesonide Inhalant Product |
| AQ001S 0.250 mg/2mL single-dose | Experimental | AQ001S 0.250 mg/2 ml (budesonide 0.250 mg/2 ml inhalation solution) single-dose administered by nebulization. Receives: Drug: Budesonide Inhalant Product |
| AQ001S 0.500 mg/2mL single-dose | Experimental | AQ001S 0.500 mg/2 ml (budesonide 0.500 mg/2 ml inhalation solution) single-dose administered by nebulization. Receives: Drug: Budesonide Inhalant Product |
| Budesonide inhalation suspension 1.0 mg/2 ml single-dose | Active comparator | Pulmicort Respules® 1.0 mg/2 ml is a budesonide inhalation suspension administered by nebulization. Receives: Drug: Budesonide Inhalant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetics (Cmax) of budesonide through analysis of blood samples
Blood samples will be collected from each subject using an indwelling intravenous catheter.
In total 17 blood samples for PK assessments over 24 hours will be collected.
Measured: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Assessment of pharmacokinetics (Tmax) of budesonide through analysis of blood samples
Blood samples will be collected from each subject using an indwelling intravenous catheter.
In total 17 blood samples for PK assessments over 24 hours will be collected.
Measured: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Assessment of pharmacokinetics (AUC) of budesonide through analysis of blood samples
Blood samples will be collected from each subject using an indwelling intravenous catheter.
In total 17 blood samples for PK assessments over 24 hours will be collected.
Measured: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Assessment of the safety through to incidence of Adverse Events of AQ001S inhalation solution
Incidence of treatment-related adverse events (AE), including acute bronchospasm
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to vital signs (blood pressure: systolic and diastolic blood pressure) of AQ001S inhalation solution
Vital signs assessment through blood pressure (systolic and diastolic blood pressure)
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to vital signs (pulse rate) of AQ001S inhalation solution
Vital signs assessment through pulse rate
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to vital signs (respiratory rate) of AQ001S inhalation solution
Vital signs assessment through respiratory rate
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (PR interval duration)
ECG assessment through to PR interval duration
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (heart rhythm) of AQ001S inhalation solution
ECG assessment through to heart rhythm
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (QRS interval duration) of AQ001S inhalation solution
ECG assessment through to QRS interval duration
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (Corrected QT interval (QTc)) of AQ001S inhalation solution
ECG assessment through to Corrected QT interval
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (QT interval duration) of AQ001S inhalation solution
ECG assessment through to QT interval duration
Measured: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to physical examination
General tolerability through the rate of patients with observed abnormalities in the following organic systems: general appearance, head and neck (incl. oropharyngeal examination), skin, respiratory system, cardiovascular system, abdomen, urogenital system, nervous system, ear, eyes and nose, musculoskeletal system
Measured: From baseline up to 17 days after first study drug intake
Assessment of the local tolerability through to increased bronchial irritability of AQ001S inhalation solution
Incidence of Increased bronchial irritability
Measured: From baseline up to 17 days after first study drug intake
Assessment of the local tolerability through to paradoxical bronchospasm of AQ001S inhalation solution
Incidence of paradoxical bronchospasm
Measured: From baseline up to 17 days after first study drug intake
Assessment of the local tolerability through to oropharyngeal examination ((e.g. vocal cord myopathy, fungal infection) of AQ001S inhalation solution
Incidence of oropharyngeal examination ((e.g. vocal cord myopathy, fungal infection)
Measured: From baseline up to 17 days after first study drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start12 Nov 2021
- Primary completion24 Dec 2021
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- The study drug will be administered by nebulization. The subjects will adhere to the following therapeutic scheme at each treatment period of 3 days, for 4 treatment periods: * One single dose of study medication on the first day of the treatment period, followed by * Minimum washout period of 3 days, i.e. minimum 72 hours between two drug administrations The pharmacokinetics profile of budesonide in plasma, will be evaluated through pharmacokinetics parameters, calculated for each single dose, and based on 17 timepoints from 0 to 24h.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquilon Pharmaceuticals S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dobrin Svinarov, MD, Principal investigator, MC Comac Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148312
- Sponsor's protocol ID
- BORA Study
- Acronym
- BORA
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single-center, Single-dose, Four-period Crossover Clinical Trial to Assess the PK Profile and Safety of Budesonide Inhalation Solution AQ001S Compared to Budesonide Inhalation Suspension in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05148312
- Acronym / sponsor ID
- BORA / BORA Study
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Aquilon Pharmaceuticals S.A.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.
Detailed description
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml.
Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization.
The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution.
The primary safety objective is to assess the safety of AQ001S inhalation solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study drug will be administered by nebulization. The subjects will adhere to the following therapeutic scheme at each treatment period of 3 days, for 4 treatment periods: * One single dose of study medication on the first day of the treatment period, followed by * Minimum washout period of 3 days, i.e. minimum 72 hours between two drug administrations The pharmacokinetics profile of budesonide in plasma, will be evaluated through pharmacokinetics parameters, calculated for each single dose, and based on 17 timepoints from 0 to 24h.
| Arm | Type | Receives |
|---|---|---|
| AQ001S 0.125 mg/2mL single-dose | Experimental | Drug: Budesonide Inhalant ProductAQ001S 0.125 mg/2 ml (budesonide 0.125 mg/2 ml inhalation solution) single-dose administered by nebulization. |
| AQ001S 0.250 mg/2mL single-dose | Experimental | Drug: Budesonide Inhalant ProductAQ001S 0.250 mg/2 ml (budesonide 0.250 mg/2 ml inhalation solution) single-dose administered by nebulization. |
| AQ001S 0.500 mg/2mL single-dose | Experimental | Drug: Budesonide Inhalant ProductAQ001S 0.500 mg/2 ml (budesonide 0.500 mg/2 ml inhalation solution) single-dose administered by nebulization. |
| Budesonide inhalation suspension 1.0 mg/2 ml single-dose | Active comparator | Drug: Budesonide Inhalant ProductPulmicort Respules® 1.0 mg/2 ml is a budesonide inhalation suspension administered by nebulization. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects who have given written informed consent.
- Healthy volunteers of both genders, aged ≥ 18 and ≤ 60 years.
- Subjects with body weight > 45 kg and Body Mass Index ≥ 18.5 and ≤ 24.9kg/m2.
- Healthy volunteers are declared healthy based on medical history, physical examination, electrocardiogram, pulmonary function test (Forced Expiratory Volume in 1 second ≥ 80% of the predicted normal value and Forced Expiratory Volume in 1 second/ Forced Vital Capacity ≥ 70%).
- Clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.
Key exclusion criteria (20 listed)
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history) or clinically relevant laboratory abnormalities.
- Clinically significant history or presence of pulmonary malformations, chronic bronchitis, asthma, emphysema, cystic fibrosis or any other pulmonary disease
- History or presence of pulmonary tuberculosis.
- Viral or bacterial upper or lower respiratory tract infection, or sinus or middle ear infection, within 4 weeks prior to the screening visit.
- Untreated oral candidiasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide Inhalant ProductAlso: Budesonide solution administered by nebulizationSingle-dose of budesonide solution administered by nebulization. | Drug | AQ001S 0.125 mg/2mL single-dose, AQ001S 0.250 mg/2mL single-dose, AQ001S 0.500 mg/2mL single-dose, Budesonide inhalation suspension 1.0 mg/2 ml single-dose |
Primary outcome
Assessment of pharmacokinetics (Cmax) of budesonide through analysis of blood samples
Time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Blood samples will be collected from each subject using an indwelling intravenous catheter. In total 17 blood samples for PK assessments over 24 hours will be collected.
Assessment of pharmacokinetics (Tmax) of budesonide through analysis of blood samples
Time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Blood samples will be collected from each subject using an indwelling intravenous catheter. In total 17 blood samples for PK assessments over 24 hours will be collected.
Assessment of pharmacokinetics (AUC) of budesonide through analysis of blood samples
Time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Blood samples will be collected from each subject using an indwelling intravenous catheter. In total 17 blood samples for PK assessments over 24 hours will be collected.
Assessment of the safety through to incidence of Adverse Events of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Incidence of treatment-related adverse events (AE), including acute bronchospasm
Assessment of the general tolerability through to vital signs (blood pressure: systolic and diastolic blood pressure) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Vital signs assessment through blood pressure (systolic and diastolic blood pressure)
Assessment of the general tolerability through to vital signs (pulse rate) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Vital signs assessment through pulse rate
Assessment of the general tolerability through to vital signs (respiratory rate) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Vital signs assessment through respiratory rate
Assessment of the general tolerability through to ECG (PR interval duration)
Time frame: From baseline up to 17 days after first study drug intake
ECG assessment through to PR interval duration
Assessment of the general tolerability through to ECG (heart rhythm) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
ECG assessment through to heart rhythm
Assessment of the general tolerability through to ECG (QRS interval duration) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
ECG assessment through to QRS interval duration
Assessment of the general tolerability through to ECG (Corrected QT interval (QTc)) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
ECG assessment through to Corrected QT interval
Assessment of the general tolerability through to ECG (QT interval duration) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
ECG assessment through to QT interval duration
Assessment of the general tolerability through to physical examination
Time frame: From baseline up to 17 days after first study drug intake
General tolerability through the rate of patients with observed abnormalities in the following organic systems: general appearance, head and neck (incl. oropharyngeal examination), skin, respiratory system, cardiovascular system, abdomen, urogenital system, nervous system, ear, eyes and nose, musculoskeletal system
Assessment of the local tolerability through to increased bronchial irritability of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Incidence of Increased bronchial irritability
Assessment of the local tolerability through to paradoxical bronchospasm of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Incidence of paradoxical bronchospasm
Assessment of the local tolerability through to oropharyngeal examination ((e.g. vocal cord myopathy, fungal infection) of AQ001S inhalation solution
Time frame: From baseline up to 17 days after first study drug intake
Incidence of oropharyngeal examination ((e.g. vocal cord myopathy, fungal infection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dobrin Svinarov, MD principal investigator
MC Comac Medical Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budesonide Inhalant Product in people with Pharmacokinetics, run by Aquilon Pharmaceuticals S.A. at 1 site in Bulgaria.
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 10 inclusion and 20 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 3 Nov 2022. 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 Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of pharmacokinetics (Cmax) of budesonide through analysis of blood samples (time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose). 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?
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 3 Nov 2022.