Healthy VolunteersPhase 1NCT05842798
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults
A Phase 1 study testing TNM002 in people with Healthy Volunteers, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TNM002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 24 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, 18-55 years of age;
- Body mass index (BMI) within 19.0-26.0 kg/m2;
Who cannot join
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
- Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;
- History of alcohol or other substance abuse.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- TNM002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM002Drug
TNM002, intramuscular injection
PlaceboDrug
Placebo, intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TNM002 35 μg/kg or placebo | Experimental | Eight subjects will be randomly assigned to receive either TNM002 35 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) Receives: Drug: TNM002; Drug: Placebo |
| Cohort 2: TNM002 100 μg/kg or placebo | Experimental | Eight subjects will be randomly assigned to receive either TNM002 100 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) Receives: Drug: TNM002; Drug: Placebo |
| Cohort 3：TNM002 250 μg/kg or placebo | Experimental | Eight subjects will be randomly assigned to receive either TNM002 250 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) Receives: Drug: TNM002; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Incidence of AEs
Measured: Up to 105 days post dosing
Number of participants with clinically significant abnormality in physical examinations
Clinically significant abnormality in general condition, skin, eyes/ears/nose/mouth/throat, neck/thyroid, chest/lungs, heart, vascular system, lymph nodes, abdomen, extremities, nervous systems/reflexes, musculoskeletal, spine
Measured: Up to 105 days post dosing
Change in Hematocrit (ratio)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Haemoglobin (g/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Platelet count (cells x 10^9/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Red blood cell count (cells x 10^12/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in differential leukocyte count (cells x 10^9/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Serum Alanine Aminotransferase (ALT) (U/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Aspartate Aminotransferase (AST) (U/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Albumin (g/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Alkaline Phosphatase (ALP) (U/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Total Bilirubin (umol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Blood urea nitrogen (BUN) (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Creatinine (umol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Calcium (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Chloride (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Cholesterol (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Creatine Kinase (U/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Glucose (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Lactate Dehydrogenase (U/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Phosphorus (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Potassium (mmol/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Total protein (g/L)
Measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Urine Bilirubin (U-BIL)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine Glucose (GLU) (mg/dL)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine erythrocytes (U-RBC)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urinary leukocyte (U-LEU)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine nitrites (U-NIT)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine protein (U-PRO)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine specific gravity (U-SG)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine urobilinogen (URO)
Measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Prothrombin time (sec)
Measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in Activated partial thromboplastin time (APTT)(sec)
Measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in fibrinogen (g/L)
Measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in international normalized ratio (INR
Measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in RR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in PR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QRS duration (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QT intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QTcB intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QTcF intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in blood pressure (mmHg)
Measured: Up to 105 days post dosing
Change in pulse rate (bpm)
Measured: Up to 105 days post dosing
Change in body temperature (celsius)
Measured: Up to 105 days post dosing
Secondary outcomes (9)
Maximum observed plasma concentration (Cmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Time of maximum plasma concentration (Tmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Terminal half-life (T1/2)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Apparent total body clearance (CL/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Apparent volume of distribution (Vz/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Measured: Up to 105 days post dosing
Anti-TNM002 antibodies
The numbers of subjects who developed anti-TNM002 antibodies
Measured: Up to 105 days post dosing
Anti-TNM002 antibodies
The percentages of subjects who developed anti-TNM002 antibodies
Measured: Up to 105 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Oct 2021
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhigang Liu, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842798
- Sponsor's protocol ID
- TNM002-P1-CH01
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in these articles after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05842798
- Acronym / sponsor ID
- TNM002-P1-CH01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 6 May 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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TNM002 35 μg/kg or placebo | Experimental | Drug: TNM002, Drug: PlaceboEight subjects will be randomly assigned to receive either TNM002 35 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) |
| Cohort 2: TNM002 100 μg/kg or placebo | Experimental | Drug: TNM002, Drug: PlaceboEight subjects will be randomly assigned to receive either TNM002 100 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) |
| Cohort 3：TNM002 250 μg/kg or placebo | Experimental | Drug: TNM002, Drug: PlaceboEight subjects will be randomly assigned to receive either TNM002 250 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female, 18-55 years of age;
- Body mass index (BMI) within 19.0-26.0 kg/m2;
Key exclusion criteria (3 listed)
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
- Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;
- History of alcohol or other substance abuse.
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 |
|---|---|---|
| TNM002TNM002, intramuscular injection | Drug | Cohort 1: TNM002 35 μg/kg or placebo, Cohort 2: TNM002 100 μg/kg or placebo, Cohort 3：TNM002 250 μg/kg or placebo |
| PlaceboPlacebo, intramuscular injection | Drug | Cohort 1: TNM002 35 μg/kg or placebo, Cohort 2: TNM002 100 μg/kg or placebo, Cohort 3：TNM002 250 μg/kg or placebo |
Primary outcome
AEs
Time frame: Up to 105 days post dosing
Incidence of AEs
Number of participants with clinically significant abnormality in physical examinations
Time frame: Up to 105 days post dosing
Clinically significant abnormality in general condition, skin, eyes/ears/nose/mouth/throat, neck/thyroid, chest/lungs, heart, vascular system, lymph nodes, abdomen, extremities, nervous systems/reflexes, musculoskeletal, spine
Change in Hematocrit (ratio)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Haemoglobin (g/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Platelet count (cells x 10^9/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Red blood cell count (cells x 10^12/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in differential leukocyte count (cells x 10^9/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Serum Alanine Aminotransferase (ALT) (U/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Aspartate Aminotransferase (AST) (U/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Albumin (g/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Alkaline Phosphatase (ALP) (U/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Total Bilirubin (umol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Blood urea nitrogen (BUN) (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Creatinine (umol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Calcium (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Chloride (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Cholesterol (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Creatine Kinase (U/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Glucose (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Lactate Dehydrogenase (U/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Phosphorus (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Potassium (mmol/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Serum Total protein (g/L)
Time frame: Up to 105 days post dosing
Measured by serum chemistry
Change in Urine Bilirubin (U-BIL)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urine Glucose (GLU) (mg/dL)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urine erythrocytes (U-RBC)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urinary leukocyte (U-LEU)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urine nitrites (U-NIT)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urine protein (U-PRO)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urine specific gravity (U-SG)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Urine urobilinogen (URO)
Time frame: Up to 105 days post dosing
Measured by Urinalysis
Change in Prothrombin time (sec)
Time frame: Up to 105 days post dosing
Measured by Blood Coagulation test
Change in Activated partial thromboplastin time (APTT)(sec)
Time frame: Up to 105 days post dosing
Measured by Blood Coagulation test
Change in fibrinogen (g/L)
Time frame: Up to 105 days post dosing
Measured by Blood Coagulation test
Change in international normalized ratio (INR
Time frame: Up to 105 days post dosing
Measured by Blood Coagulation test
Change in RR intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in PR intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in QRS duration (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in QT intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in QTcB intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in QTcF intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in blood pressure (mmHg)
Time frame: Up to 105 days post dosing
Change in pulse rate (bpm)
Time frame: Up to 105 days post dosing
Change in body temperature (celsius)
Time frame: Up to 105 days post dosing
9 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to 105 days post dosing
Time of maximum plasma concentration (Tmax)
Time frame: Up to 105 days post dosing
Terminal half-life (T1/2)
Time frame: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Time frame: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Time frame: Up to 105 days post dosing
Apparent total body clearance (CL/F)
Time frame: Up to 105 days post dosing
Apparent volume of distribution (Vz/F)
Time frame: Up to 105 days post dosing
Anti-TNM002 antibodies
Time frame: Up to 105 days post dosing
Anti-TNM002 antibodies
Time frame: Up to 105 days post dosing
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 6 May 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in these articles after deidentification
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Zhigang Liu principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
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 TNM002 in people with Healthy Volunteers, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in China.
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 2 inclusion and 3 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 6 May 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 China. 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?
AEs (time frame: Up to 105 days post dosing). The study lists 44 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 6 May 2023.