Bacterial InfectionsPhase 1NCT04801043
To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.
A Phase 1 study testing XNW4107 and Imipenem/Cilastatin in people with Bacterial Infections, run by Evopoint Biosciences Inc. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- XNW4107 and Imipenem/Cilastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 31 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Healthy adult female, 18 to 45 years of age (both inclusive) or 65 years or over (≥ 65 years); or healthy adult male 65 years or over (≥ 65 years).
- 2. BMI ≥ 18.0 and ≤ 32.0 (kg/m²) and weight between 55.0 and 100.0 kg (inclusive).
- 3. Medically healthy without clinically significant abnormalities as assessed by the Investigator based on Screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis.
- 4. Male or female, willing to contracept. If female, must be non-pregnant and non-lactating.
- 5. Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or product containing any of these from 48 hours prior to study drug administration until discharge from the clinical unit.
Who cannot join
- 1. History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant.
- 2. Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females obtained after at least 5 minutes in a supine or semi-supine position at quiet rest at Screening or Check-In (Day -1).
- 3. Subjects who have any of the following abnormalities on laboratory values at Screening or prior confinement including: • White blood cell count < 3,000/mm³, hemoglobin < 11g/dL; • Absolute neutrophil count <1,200/mm³, platelet count <120,000/mm³; • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory.
- 4. History of seizure disorder except childhood history of febrile seizures.
- 5. Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.
- 6. Close contact with anyone who tested positive for SARS-CoV-2 infection, or presence of symptoms associated with SARS-CoV-2 infection at Screening or Check-in, or within 14 days prior to Screening.
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- 7. Recent history (within 6 months) of known or suspected Clostridium difficile infection.
- 8. Positive testing for HIV Ab, HBsAg or HCV Ab.
- 9.Positive urine drug or alcohol testing at screening or check-in (Day -1).
- 10.Use of prescription medications (with the exception of hormone replacement therapy and contraceptives), including nonsteroidal anti-inflammatory drugs, sucralfate, or herbal preparations within 7 days before Check in (Day -1), or use of an over-the-counter medication, acetaminophen (>2 g/day), vitamins, or supplements (including fish liver oils) within 7 days before Check in (Day -1); or probenecid or valproic acid within 30 days before Check in (Day -1).
- 11. Receipt of an investigational drug within 30 days or 5 half-lives prior to the first administration of study drug, whichever is longer.
- 12. Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication, or history of clinically significant hypersensitivity to the study drug or any related drugs or to any of the excipients, or significant food intolerance.
- 13. Donation of blood or plasma within 30 days prior to dosing, or loss of whole blood of more than 500 mL within 30 days prior to dosing, or receipt of a blood transfusion within 1 year of study enrollment.
- 14. Any other condition or prior therapy, which, in the opinion of the Investigator, would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809-3017
About this study
Official title: A Phase 1, Single-Dose, Randomized, Double Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of XNW4107 for Injection in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.
This is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females.
- Conditions
- Bacterial Infections
- Being tested
- XNW4107, Imipenem/Cilastatin, placebo
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XNW4107Drug
XNW4107 250mg IV over 60 minutes as a single dose
Imipenem/CilastatinDrug
500mg/500mg IV over 60 minutes as a single dose
placeboDrug
Matching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose
Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Healthy young females | Experimental | Healthy young females participants, ≥ 18 to ≤ 45 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg. Receives: Drug: XNW4107; Drug: Imipenem/Cilastatin |
| Cohort 2: Healthy elderly males | Experimental | Healthy elderly male participants, ≥ 65 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg. Receives: Drug: XNW4107; Drug: Imipenem/Cilastatin |
| Cohort 3: Healthy elderly females | Experimental | Healthy elderly female participants, ≥ 65 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg. Receives: Drug: XNW4107; Drug: Imipenem/Cilastatin |
| Placebo to XNW 4107 & imipenem/cilastatin | Placebo comparator | Matching placebo for XNW4107 and imipenem/cilastatin Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Plasma)Total body clearance (CL/F) of of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Plasma) Area under the curve from time zero to the last quantifiable sample (AUC0-last) of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Plasma) AUC extrapolated to infinity (AUC0-∞) of of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Plasma) Apparent steady-state volume of distribution (Vss/F) of of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Plasma) Maximum plasma concentration (Cmax) of of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Plasma) Time to the maximum plasma concentration (Tmax) of of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Plasma) The terminal elimination half-life (t1/2) of XNW4107, imipenem and cilastatin.
Measured: From baseline to 48 hours post-dose
(Urine) Renal clearance (CLR) of the XNW4107, imipenem and cilastatin dose administered.
Measured: From baseline to 48 hours post-dose
(Urine) Fraction of drug excreted in the urine expressed as a percentage of the XNW4107, imipenem and cilastatin dose administered (Ae%)
Measured: From baseline to 48 hours post-dose
(Urine) Amount of drug excreted in the urine through 24 hours (Ae0-24)
Measured: From baseline to 24 hours post-dose
(Urine) Amount of drug excreted in the urine through 48 hours (Ae0-48)
Measured: From baseline to 48 hours post-dose
Secondary outcomes (7)
Number of participants with treatment-related adverse events of Hematology as assessed by CTCAE v5.0
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Hematology including White cell count with differential (total and % of neutrophil, lymphocyte, monocyte, eosinophil, and basophil), red blood cell count in m/mm³, hemoglobin in g/dL, hematocrit in %, mean corpuscular volume and platelet count m/mm³.
Measured: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Physical Examination as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in Physical Examination of the following body systems: HEENT; cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance, and in kilograms, height in meters and weight and height will be combined to report BMI in kg/m².
Measured: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Vital Signs as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in Vital Signs (Systolic and diastolic blood pressure in mmHg, heart rate in Beats per min, respiratory rate in Breaths per min, and oral temperature in Degree celsius).
Measured: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of 12-Lead Electrocardiogram (ECG) as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in 12-Lead Electrocardiogram including heart rate(bpm), RR interval(ms), PR interval(ms), QRS(ms), QT(ms) and QTcF(ms).
Measured: From baseline up to 3 days post-dose
Number of participants with treatment-related adverse events of Biochemistry as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Biochemistry including Sodium in mmol/L, calcium in mg/dL, phosphate in mg/dL, potassium in mmol/L, chloride in mmol/L, glucose in mg/dl, BUN in mg/dl, uric acid in mg/dl, creatinine in mg/dL, creatine kinase in IU/L, creatinine clearance calculated in ml/min/1.73m² , total bilirubin in mg/dL, direct bilirubin in mg/dL, alkaline phosphatase in IU/L, ALT in IU/L, AST in IU/L, lactate dehydrogenase in IU/L, gamma-glutamyl transferase in IU/L, total protein in g/dL, albumin in g/dL, triglycerides in mg/dL, and cholesterol in mg/dL.
Measured: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Coagulation as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Coagulation including Prothrombin time in seconds, activated partial thromboplastin time in seconds and International Normalized Ratio (INR).
Measured: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Urinalysis as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Urinalysis Specific gravity, pH, leukocyte esterase, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen.
Measured: From baseline up to 10 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start2 Mar 2021
- Primary completion30 Oct 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Evopoint Biosciences Inc.The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801043
- Sponsor's protocol ID
- XNW4107-002
- Status last verified
- Feb 2023
- First submitted
- 7 Mar 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Randomized, Double Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of XNW4107 for Injection in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.
- ClinicalTrials.gov ID
- NCT04801043
- Acronym / sponsor ID
- XNW4107-002
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 16 Mar 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 Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Healthy young females | Experimental | Drug: XNW4107, Drug: Imipenem/CilastatinHealthy young females participants, ≥ 18 to ≤ 45 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg. |
| Cohort 2: Healthy elderly males | Experimental | Drug: XNW4107, Drug: Imipenem/CilastatinHealthy elderly male participants, ≥ 65 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg. |
| Cohort 3: Healthy elderly females | Experimental | Drug: XNW4107, Drug: Imipenem/CilastatinHealthy elderly female participants, ≥ 65 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg. |
| Placebo to XNW 4107 & imipenem/cilastatin | Placebo comparator | Drug: placeboMatching placebo for XNW4107 and imipenem/cilastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Healthy adult female, 18 to 45 years of age (both inclusive) or 65 years or over (≥ 65 years); or healthy adult male 65 years or over (≥ 65 years).
- 2. BMI ≥ 18.0 and ≤ 32.0 (kg/m²) and weight between 55.0 and 100.0 kg (inclusive).
- 3. Medically healthy without clinically significant abnormalities as assessed by the Investigator based on Screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis.
- 4. Male or female, willing to contracept. If female, must be non-pregnant and non-lactating.
- 5. Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or product containing any of these from 48 hours prior to study drug administration until discharge from the clinical unit.
Key exclusion criteria (14 listed)
- 1. History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant.
- 2. Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females obtained after at least 5 minutes in a supine or semi-supine position at quiet rest at Screening or Check-In (Day -1).
- 3. Subjects who have any of the following abnormalities on laboratory values at Screening or prior confinement including: • White blood cell count < 3,000/mm³, hemoglobin < 11g/dL; • Absolute neutrophil count <1,200/mm³, platelet count <120,000/mm³; • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory.
- 4. History of seizure disorder except childhood history of febrile seizures.
- 5. Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.
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 |
|---|---|---|
| XNW4107XNW4107 250mg IV over 60 minutes as a single dose | Drug | Cohort 1: Healthy young females, Cohort 2: Healthy elderly males, Cohort 3: Healthy elderly females |
| Imipenem/Cilastatin500mg/500mg IV over 60 minutes as a single dose | Drug | Cohort 1: Healthy young females, Cohort 2: Healthy elderly males, Cohort 3: Healthy elderly females |
| placeboMatching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose | Drug | Placebo to XNW 4107 & imipenem/cilastatin |
Primary outcome
(Plasma)Total body clearance (CL/F) of of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Plasma) Area under the curve from time zero to the last quantifiable sample (AUC0-last) of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Plasma) AUC extrapolated to infinity (AUC0-∞) of of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Plasma) Apparent steady-state volume of distribution (Vss/F) of of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Plasma) Maximum plasma concentration (Cmax) of of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Plasma) Time to the maximum plasma concentration (Tmax) of of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Plasma) The terminal elimination half-life (t1/2) of XNW4107, imipenem and cilastatin.
Time frame: From baseline to 48 hours post-dose
(Urine) Renal clearance (CLR) of the XNW4107, imipenem and cilastatin dose administered.
Time frame: From baseline to 48 hours post-dose
(Urine) Fraction of drug excreted in the urine expressed as a percentage of the XNW4107, imipenem and cilastatin dose administered (Ae%)
Time frame: From baseline to 48 hours post-dose
(Urine) Amount of drug excreted in the urine through 24 hours (Ae0-24)
Time frame: From baseline to 24 hours post-dose
(Urine) Amount of drug excreted in the urine through 48 hours (Ae0-48)
Time frame: From baseline to 48 hours post-dose
7 secondary outcomes
Number of participants with treatment-related adverse events of Hematology as assessed by CTCAE v5.0
Time frame: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Physical Examination as assessed by CTCAE v5.0.
Time frame: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Vital Signs as assessed by CTCAE v5.0.
Time frame: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of 12-Lead Electrocardiogram (ECG) as assessed by CTCAE v5.0.
Time frame: From baseline up to 3 days post-dose
Number of participants with treatment-related adverse events of Biochemistry as assessed by CTCAE v5.0.
Time frame: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Coagulation as assessed by CTCAE v5.0.
Time frame: From baseline up to 10 days post-dose
Number of participants with treatment-related adverse events of Urinalysis as assessed by CTCAE v5.0.
Time frame: From baseline up to 10 days post-dose
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 16 Feb 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 XNW4107 and Imipenem/Cilastatin in people with Bacterial Infections, run by Evopoint Biosciences Inc. 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 5 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 16 Feb 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. Some participants in this study may receive a placebo. 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?
(Plasma)Total body clearance (CL/F) of of XNW4107, imipenem and cilastatin. (time frame: From baseline to 48 hours post-dose). The study lists 11 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 16 Feb 2023.