Nonalcoholic SteatohepatitisPhase 1NCT05983328
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
A Phase 1 study testing HUYPS-1 one tablet and HUYPS-1 nine tablets in people with Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc. at 1 site in Taiwan.
Trial summary
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period. Period: 24 hours post dose in each period. Each subject will complete two study periods. Washout Period: At least one week after dosing of the previous period. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- HUYPS-1 one tablet and HUYPS-1 nine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2016to 9 Feb 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy adult subjects between 20-50 years of age.
- Acceptable medical history and physical examination including:
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and galactose single point (GSP).
- Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
- Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
- Signed the written informed consent to participate in this study.
- Acceptable body mass index (BMI): 18.5 < BMI < 25 kg/m2
Who cannot join
- Recent history of drug or alcohol addiction or abuse within the past year.
- A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- History of allergic response(s) to mannitol, sucralose or related drugs.
- History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- Evidence of chronic or acute infectious diseases.
- Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).
Show all 14Show fewer
- Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
- Receiving any investigational drug within one month prior to Period I dosing.
- Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
- Donating greater than 150 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol, smoke or use tobacco products within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
- Any other medical reason as determined by the clinical investigator.
- Subject is pregnant or breastfeeding.
- Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Design Phase I Study to Evaluate Tolerability, Safety and Pharmacokinetics of HUYPS-1 in Healthy Volunteers
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period.
Period: 24 hours post dose in each period. Each subject will complete two study periods.
Washout Period: At least one week after dosing of the previous period.
Confinement: From at least 10 hours prior to dosing until at least 12 hours post-dose, for a total of at least 22 hours for each study period.
Read the detailed description
This study is a single center and open-label design to evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after single oral administration in healthy subjects under fasting conditions. A total of 14 eligible subjects are expected to be enrolled to ensure 12 evaluable subjects. The study will be completed when there are at least 12 evaluable subjects. The evaluable subjects are those who have completed both periods. Eligible subjects will be randomly assigned to either of the two treatment sequences.
The study design in a 2-sequence, 2-period crossover design. There is at least 7-day washout time between periods. The formulation of HUYPS-1 for oral administration contains 100 mg mannitol and 100 mg sucralose per tablet will be given by one or nine tablets per person of each period. Mannitol and sucralose are both commonly used excipients approved by WHO. These excipients are included in the FDA Inactive Ingredients Guide, GRAS (generally recognized as safe) and commonly used pharmaceutical excipients, therefore the oral doses of these excipients can be regarded as extremely safe in this study.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- HUYPS-1 one tablet, HUYPS-1 nine tablets
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUYPS-1 one tabletDrug
After 7-day washout time, subjects will receive HUYPS-1 1 tablet.
HUYPS-1 nine tabletsDrug
After 7-day washout time, subjects will receive HUYPS-1 9 tablets.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers dose 1 | Experimental | Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 1 tablet oral administration in healthy subjects Receives: Drug: HUYPS-1 one tablet |
| Healthy Volunteer dose 2 | Experimental | Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 9 tablets oral administration in healthy subjects Receives: Drug: HUYPS-1 nine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 24 hours
Secondary outcomes (11)
Pharmacokinetic profile of maximum concentration of HUYPS-1 (Cmax)
Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
Cmax
Measured: 24 hours
Pharmacokinetic profile of time of occurrence for maximum (peak) HUYPS-1 concentration (Tmax)
Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
Tmax
Measured: 24 hours
Pharmacokinetic profile of area under curve (AUC0-t) for HUYPS-1
Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
AUC0-t
Measured: 24 hours
Pharmacokinetic profile of area under curve infinity (AUCINF) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
AUCINF
Measured: 24 hours
Pharmacokinetic profile of overall HUYPS-1 elimination rate constant (k)
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
k
Measured: 24 hours
Pharmacokinetic profile of elimination half-life (T1/2) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
T1/2
Measured: 24 hours
Pharmacokinetic profile of mean residence time (MRT) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
MRT
Measured: 24 hours
Pharmacokinetic profile of clearance (CL/F) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
CL/F
Measured: 24 hours
Pharmacokinetic profile of apparent volume (Vd/F) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
Vd/F
Measured: 24 hours
Pharmacokinetic profile of area under moment curve (AUMC(0-t)) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
AUMC(0-t)
Measured: 24 hours
Pharmacokinetic profile of area under moment curve infinity (AUMCINF) for HUYPS-1
LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
The following parameters of HUYPS-1 will be determined using WINNONLINTM:
AUMCINF
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start10 May 2016
- Primary completion26 May 2016
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinew Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983328
- Sponsor's protocol ID
- Oral HUYPS-1-001
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2018
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Design Phase I Study to Evaluate Tolerability, Safety and Pharmacokinetics of HUYPS-1 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05983328
- Acronym / sponsor ID
- Oral HUYPS-1-001
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sinew Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2016 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 9 Aug 2023 (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.
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period.
Period: 24 hours post dose in each period. Each subject will complete two study periods.
Washout Period: At least one week after dosing of the previous period.
Confinement: From at least 10 hours prior to dosing until at least 12 hours post-dose, for a total of at least 22 hours for each study period.
Detailed description
This study is a single center and open-label design to evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after single oral administration in healthy subjects under fasting conditions. A total of 14 eligible subjects are expected to be enrolled to ensure 12 evaluable subjects. The study will be completed when there are at least 12 evaluable subjects. The evaluable subjects are those who have completed both periods. Eligible subjects will be randomly assigned to either of the two treatment sequences.
The study design in a 2-sequence, 2-period crossover design. There is at least 7-day washout time between periods. The formulation of HUYPS-1 for oral administration contains 100 mg mannitol and 100 mg sucralose per tablet will be given by one or nine tablets per person of each period. Mannitol and sucralose are both commonly used excipients approved by WHO. These excipients are included in the FDA Inactive Ingredients Guide, GRAS (generally recognized as safe) and commonly used pharmaceutical excipients, therefore the oral doses of these excipients can be regarded as extremely safe in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers dose 1 | Experimental | Drug: HUYPS-1 one tabletEvaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 1 tablet oral administration in healthy subjects |
| Healthy Volunteer dose 2 | Experimental | Drug: HUYPS-1 nine tabletsEvaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 9 tablets oral administration in healthy subjects |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal healthy adult subjects between 20-50 years of age.
- Acceptable medical history and physical examination including:
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and galactose single point (GSP).
- Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
- Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
Key exclusion criteria (14 listed)
- Recent history of drug or alcohol addiction or abuse within the past year.
- A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- History of allergic response(s) to mannitol, sucralose or related drugs.
- History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- Evidence of chronic or acute infectious diseases.
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 |
|---|---|---|
| HUYPS-1 one tabletAfter 7-day washout time, subjects will receive HUYPS-1 1 tablet. | Drug | Healthy Volunteers dose 1 |
| HUYPS-1 nine tabletsAfter 7-day washout time, subjects will receive HUYPS-1 9 tablets. | Drug | Healthy Volunteer dose 2 |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):
Time frame: 24 hours
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
11 secondary outcomes
Pharmacokinetic profile of maximum concentration of HUYPS-1 (Cmax)
Time frame: 24 hours
Pharmacokinetic profile of time of occurrence for maximum (peak) HUYPS-1 concentration (Tmax)
Time frame: 24 hours
Pharmacokinetic profile of area under curve (AUC0-t) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of area under curve infinity (AUCINF) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of overall HUYPS-1 elimination rate constant (k)
Time frame: 24 hours
Pharmacokinetic profile of elimination half-life (T1/2) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of mean residence time (MRT) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of clearance (CL/F) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of apparent volume (Vd/F) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of area under moment curve (AUMC(0-t)) for HUYPS-1
Time frame: 24 hours
Pharmacokinetic profile of area under moment curve infinity (AUMCINF) for HUYPS-1
Time frame: 24 hours
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 9 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HUYPS-1 one tablet and HUYPS-1 nine tablets in people with Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc. at 1 site in Taiwan.
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 7 inclusion and 14 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 9 Aug 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 Taiwan. 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): (time frame: 24 hours). 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 9 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.