Rabies Virus InfectionPhase 2NCT06548139
Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials
A Phase 2 study testing Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg, Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg and Rabies Human Immunoglobulin (HRIG) in people with Rabies Virus Infection, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Virus Infection
- What is being tested?
- Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg, Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg and Rabies Human Immunoglobulin (HRIG)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 31 May 2025
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Before the trial, I have had a detailed understanding of the nature, significance and possible benefits of the trial, the possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, was able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;
- Men or women aged 18~50 (including boundary values) at the time of screening;
- The weight of female volunteers was 45.0 kg and 80.0 kg, that of male volunteers was 50.0 kg and 80.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg/m2 (including boundary value) (BMI= weight kg / height m2);
- Female volunteers have no fertility or egg donation plan within 14 days before the first dose to 3 months after the end of the trial and voluntarily take effective physical contraception, while male volunteers have no fertility or sperm donation plan within 3 months after the first dose to the trial and voluntarily take effective physical contraception.
Who cannot join
- Those who are known to be allergic to the study drug (including excipients, similar drugs), or suffer from severe allergic diseases or allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers in the judgment of the investigator (inquiry);
- Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
- Patients with a history of clinically serious disease within 6 months (180 days) before the first dose and not cured, or patients with acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry);
- Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);
- Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);
- Those who have received major surgery within 3 months (90 days) prior to the first dose, or those who may significantly affect the internal process or safety evaluation of the study drug (inquiry, inquiry);
Show all 28Show fewer
- Patients with a history of rabies virus infection or have received rabies vaccination (inquiry);
- Suspected or clear identification of a history of injuries to warm-blooded mammals in the last 12 months (360 days) (warm-blooded animals refer to animals that can regulate their body temperature, also known as endotherms. Birds and the vast majority of mammals, including the cats and dogs around them, are warm-blooded animals) (inquiry);
- Having received a vaccine other than the rabies vaccine within 1 month (30 days) prior to the first dose (inquiry);
- Those who have used a rabies passive immunization preparation or used systemic immunosuppressive agents such as glucocorticoids within 3 months (90 days) prior to the first dose (inquiry, inquiry)；
- Those who have been used or are in the current period) or who may have a significant impact on the in vivo process or safety evaluation of the study drug (inquiry, inquiry);
- Any clinical trial drug or device used within 3 months (90 days) prior to the first dose, or <5 half-lives of the last previous trial drug dose (whichever is older), or planned to participate in other clinical trials during the study (inquiry, inquiry);
- Regular alcohol for 3 months (90 days) before the first dose (3 times a week, and an average of 50° of liquor 200 ml) (inquiry);
- Those with positive alcohol breath test or test value> 0 mg / 100 ml (examination);
- Cigarette addiction (more than 10 cigarettes or the same amount of tobacco per day) within 1 month (30 days) before the first dose (inquiry);
- Those who lost blood / donated more than 400 ml (other than female physiological blood loss) within 3 months (90 days) before the first dose, or who received blood transfusion or used blood products, or planned to donate blood during the trial or within 1 month (30 days) after the end of the trial (inquiry);
- Those who ingested alcohol-containing products within 24 hours before the first dose (inquiry);
- Abnormalities at the administration site (such as inflammation, induration, redness, large area scar or tattoo, etc.) shall affect the administration or the clinical observer (examination);
- Those with a history of substance abuse (inquiry);
- Those who are screened positive for substance abuse during the screening period (examination);
- Those who are positive for the initial HIV screening during the screening period (screening);
- two half and half qualitative tests of hepatitis B during the screening period (examination);
- Patients with positive results for hepatitis C virus antibody or treponema pallidum antibody during the screening period (examination);
- Physical examination, vital signs (respiration, blood pressure, pulse rate), electrocardiogram, other laboratory tests (laboratory tests not listed separately) or other auxiliary examination results are judged as abnormal and clinically significant by the study doctor (examination);
- Ear temperature during the screening period is> 37.5℃ (examination);
- Women who are positive in pregnancy or lactation or screening pregnancy test (inquiry, examination);
- Patients with a history of needle acupuncture, blood sickness, or unable to tolerate venipuncture (inquiry);
- The volunteers may be unable to cooperate with the study for other reasons or the investigators is not unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Kunming, Yunnan, 650000
About this study
Official title: Multicenter, Randomized, Double-blind, Positive Control Evaluation of Rabies Monomab CBB 1 Combination Vaccine for Antibody Neutralization Activity and Safety Phase Clinical Trials in Healthy People
To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people
Read the detailed description
To evaluate the rabies virus neutralizing antibody (RVNA) activity of rabies mAb CBB 1 in combination with human rabies vaccine (Vero cells) in healthy volunteers.
To evaluate the safety and tolerability of rabies mAb CBB 1 compared to HRIG in combination with human rabies vaccine (Vero cells) in healthy volunteers.
To evaluate the immunogenicity of rabies mAb CBB 1.
- Conditions
- Rabies Virus Infection
- Being tested
- Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg, Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg, Rabies Human Immunoglobulin (HRIG), Lyophilized rabies vaccine for human use (Vero cells)
- Keywords
- Rabies Virus Neutralizing Antibodies, Safety, Immunogenicity
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural full human monoclonal antibody CBB 1 injection 50.0µg/kgDrug
Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
Natural full human monoclonal antibody CBB 1 injection 100.0µg/kgDrug
Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
Rabies Human Immunoglobulin (HRIG)Drug
Active ingredient: Rabid human immunoglobulin
Lyophilized rabies vaccine for human use (Vero cells)Biological
Active ingredient: inactivated rabies virus fixed poison
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Natural full human monoclonal antibody CBB 1 injection：Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart. Receives: Drug: Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg; Biological: Lyophilized rabies vaccine for human use (Vero cells) |
| Experimental group 2 | Experimental | Natural full human monoclonal antibody CBB 1 injection：Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart. Receives: Drug: Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg; Biological: Lyophilized rabies vaccine for human use (Vero cells) |
| Positive control group | Active comparator | Rabies Human Immunoglobulin (HRIG) Active ingredient: Rabid human immunoglobulin Specification: 200 IU / 2 ml / bottle Administration mode: intramuscular injection of the vastus lateral muscle group.
Usage and dosage: the injection dose was calculated according to the body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site and at least 2.5 cm apart Receives: Drug: Rabies Human Immunoglobulin (HRIG); Biological: Lyophilized rabies vaccine for human use (Vero cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabia for neutralizing antibody activity
Geometric mean RVNA concentration on day 7 after medication; Proportion of volunteers with 0.5 IU / ml of RVNA on day 7 after medication.
Measured: 7 Days
Secondary outcomes (9)
Rabia for neutralizing antibody activity
RVNA detection rate at days 0.5,1,2,3,5,7,14,28,42,84, and 105 after drug administration.
Geometric mean concentration and relative antibody positive rate at days 0.5,1,2,3,5,105,28,42,84,105 (RVNA 0.5 IU / ml).
Measured: 105 Days
Safety evaluation index
Clinical indicators:Physical examination.
Measured: 105 Days
Safety evaluation index
Vital signs: ear temperature/℃
Measured: 105 Days
Safety evaluation index
Vital signs: blood pressure (sitting position)/mmHg
Measured: 105 Days
Safety evaluation index
Vital signs: pulse rate/Time / minute.
Measured: 105 Days
Safety evaluation index
12-lead ECG all were abnormal and clinically significant by the investigator
Measured: 105 Days
Safety evaluation index
local reaction;constitutional reaction.
Measured: 105 Days
Safety evaluation index
Laboratory indicator all were abnormal and clinically significant by the investigator
Measured: 105 Days
Immunogenicity evaluation index
Positive rate of anti-drug antibodies (ADA) on days 14,28,84,105 after administration. If ADA positive, continue to evaluate whether it is rabies mAb CBB 1 neutralizing antibody
Measured: 105 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start31 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Virus InfectionStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There were 120 healthy people aged 10-50 years, divided into 3 groups: test group 1 rabies mAb CBB1 50.0 µ g / kg + vaccine; test group 2 rabies mAb CBB1 100.0 µ g / kg + vaccine; and control group HRIG 20IU / kg + vaccine
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Anning City First People's Hospital, Yunnan Central Hospital, Beijing Contreke Statistical Technology Co., LTD, Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548139
- Sponsor's protocol ID
- B1801-F20220212
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Positive Control Evaluation of Rabies Monomab CBB 1 Combination Vaccine for Antibody Neutralization Activity and Safety Phase Clinical Trials in Healthy People
- ClinicalTrials.gov ID
- NCT06548139
- Acronym / sponsor ID
- B1801-F20220212
- Conditions
- Rabies Virus Infection
- Keywords
- Rabies Virus Neutralizing Antibodies, Safety, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Anning City First People's Hospital, Yunnan Central Hospital, Beijing Contreke Statistical Technology Co., LTD, Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 12 Aug 2024 (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.
To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people
Detailed description
To evaluate the rabies virus neutralizing antibody (RVNA) activity of rabies mAb CBB 1 in combination with human rabies vaccine (Vero cells) in healthy volunteers.
To evaluate the safety and tolerability of rabies mAb CBB 1 compared to HRIG in combination with human rabies vaccine (Vero cells) in healthy volunteers.
To evaluate the immunogenicity of rabies mAb CBB 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- There were 120 healthy people aged 10-50 years, divided into 3 groups: test group 1 rabies mAb CBB1 50.0 µ g / kg + vaccine; test group 2 rabies mAb CBB1 100.0 µ g / kg + vaccine; and control group HRIG 20IU / kg + vaccine
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg, Biological: Lyophilized rabies vaccine for human use (Vero cells)Natural full human monoclonal antibody CBB 1 injection：Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart. |
| Experimental group 2 | Experimental | Drug: Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg, Biological: Lyophilized rabies vaccine for human use (Vero cells)Natural full human monoclonal antibody CBB 1 injection：Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart. |
| Positive control group | Active comparator | Drug: Rabies Human Immunoglobulin (HRIG), Biological: Lyophilized rabies vaccine for human use (Vero cells)Rabies Human Immunoglobulin (HRIG) Active ingredient: Rabid human immunoglobulin Specification: 200 IU / 2 ml / bottle Administration mode: intramuscular injection of the vastus lateral muscle group. Usage and dosage: the injection dose was calculated according to the body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site and at least 2.5 cm apart |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Before the trial, I have had a detailed understanding of the nature, significance and possible benefits of the trial, the possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, was able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;
- Men or women aged 18~50 (including boundary values) at the time of screening;
- The weight of female volunteers was 45.0 kg and 80.0 kg, that of male volunteers was 50.0 kg and 80.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg/m2 (including boundary value) (BMI= weight kg / height m2);
- Female volunteers have no fertility or egg donation plan within 14 days before the first dose to 3 months after the end of the trial and voluntarily take effective physical contraception, while male volunteers have no fertility or sperm donation plan within 3 months after the first dose to the trial and voluntarily take effective physical contraception.
Key exclusion criteria (28 listed)
- Those who are known to be allergic to the study drug (including excipients, similar drugs), or suffer from severe allergic diseases or allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers in the judgment of the investigator (inquiry);
- Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
- Patients with a history of clinically serious disease within 6 months (180 days) before the first dose and not cured, or patients with acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry);
- Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);
- Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);
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 |
|---|---|---|
| Natural full human monoclonal antibody CBB 1 injection 50.0µg/kgActive ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection | Drug | Experimental group 1 |
| Natural full human monoclonal antibody CBB 1 injection 100.0µg/kgActive ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection | Drug | Experimental group 2 |
| Rabies Human Immunoglobulin (HRIG)Active ingredient: Rabid human immunoglobulin | Drug | Positive control group |
| Lyophilized rabies vaccine for human use (Vero cells)Active ingredient: inactivated rabies virus fixed poison | Biological | Experimental group 1, Experimental group 2, Positive control group |
Primary outcome
Rabia for neutralizing antibody activity
Time frame: 7 Days
Geometric mean RVNA concentration on day 7 after medication; Proportion of volunteers with 0.5 IU / ml of RVNA on day 7 after medication.
9 secondary outcomes
Rabia for neutralizing antibody activity
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Safety evaluation index
Time frame: 105 Days
Immunogenicity evaluation index
Time frame: 105 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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 2 study testing Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg, Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg and Rabies Human Immunoglobulin (HRIG) in people with Rabies Virus Infection, run by Changchun BCHT Biotechnology Co. 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 4 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Rabia for neutralizing antibody activity (time frame: 7 Days). 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 12 Aug 2024.