Healthy VolunteersPhase 1NCT05987488
ShigETEC Vaccine Study in Bangladesh
A Phase 1 study testing ShigETEC live, attenuated, oral vaccine in people with Healthy Volunteers, run by Eveliqure Biotechnologies GmbH at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months). Read more about this study
- Who is it for?
- Ages 6 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ShigETEC live, attenuated, oral vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteBangladesh
- Study dates
- 26 Nov 2023to 1 Dec 2025
- 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 6 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female adults, children, toddlers, and infants aged between 18-45 years, 2-5 years, 12-23 months, and 6-11 months, respectively at the time of vaccination.
- Free of obvious health problems as determined by medical history and clinical examination before entering into the study.
- Normal bowel habits.
- Informed consent form signed.
- Negative pregnancy tests before each vaccination for females of childbearing potential. Adult participants agree to use birth control steps or abstinence.
Who cannot join
- Nursing and breast-feeding women.
- Presence of any known significant medical or psychiatric condition / systemic disorder.
- History of congenital abdominal disorders, intussusception, abdominal surgery, any other congenital disorder, any neurologic disorders or seizures.
- Clinically significant abnormalities in screening hematology, serum chemistry.
- Known or suspected HIV, hepatitis infection.
- Clinical evidence of active gastrointestinal illness or acute disease at the time of enrolment.
Show all 14Show fewer
- Prior receipt of any Shigella or ETEC vaccine, blood transfusion or blood products.
- History of febrile illness within 48 hours prior to vaccination or fever at the time of immunization.
- History of diarrhoea within 7 days and / or acute diarrhoea due to culture confirmed Shigella or ETEC infections within one month prior to vaccination.
- Screening stool positive for any Shigella or ETEC strain by culture.
- Participation in research involving another investigational product within 30 days before before planned date of first vaccination concurrent participation in another clinical trial.
- Receipt of antimicrobial drugs for any reason within 7 days before vaccination.
- Allergy to quinolone, sulfa, and penicillin classes of antibiotics
- Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka
About this study
Official title: Early Clinical Development of a Live, Attenuated Combination Vaccine Against Shigella and ETEC Diarrhoea: Phase 1b Clinical Trial of ShigETEC Vaccine in Bangladeshi Adults and Three Paediatric Age Groups
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months).
The main question[s] it aims to answer are:
- Safety and clinical tolerability of the vaccine
- Immune responses generated by the vaccine In the age-descending dose-escalating study
- Adult participants will be divided into 2 escalating dose cohorts
- Each age group of paediatric participants will be divided into 3 escalating dose cohorts
- Participants in each cohort will receive three doses of vaccine/placebo two weeks apart
- Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be monitored after each vaccination dose
- Stool samples will be collected for immunological analysis and shedding of vaccine strain
- Blood samples will be collected for immunological analysis
Read the detailed description
A double-blind, randomized, placebo-controlled, age-descending and dose-escalating phase 1b clinical trial will be carried out in Bangladeshi adults and three paediatric age groups to evaluate the safety, clinical tolerance, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine.
Objectives of the study
Primary Objectives:
To evaluate the safety and clinical tolerability of oral ShigETEC vaccine in Bangladeshi adults and different age groups of paediatric participants by monitoring the occurrence and severity of clinical signs and symptoms after administration of each of the three vaccinations.
Secondary Objectives:
- To evaluate the immune response to Shigella and ETEC (Enterotoxigenic Escherichia coli) antigens in blood and stool following administration of ShigETEC vaccine.
- To assess the fecal shedding of ShigETEC following ingestion.
The age-descending study will start testing the vaccine in healthy adults (aged 18-45 years) and move subsequently into three different paediatric age groups (aged 2-5 years, 12-23 months and 6-11 months). In the adult participants (group A), fifty-four participants will be enrolled and divided into 3 escalating dose cohorts. Each cohort of 18 healthy adults (12 vaccinees and 6 placebo recipients) will be randomized to receive three times vaccine/placebo two weeks apart. The first adult cohort (cohort A1) will receive the optimal vaccine dose (OVD) found in Phase I Europe trial (5x10^10 CFU). Cohort A2 will be given 4-fold higher dose than cohort A1 (2x10^11 CFU). Cohort A3 will receive a lower dose according to DSMB decision (2x10^9 CFU).
In each of the 2-5 years (group B), 12-23 months (group C), and 6-11 months age group (group D), 48 participants will be enrolled and divided into 3 escalating dose cohorts with 16 participants in each cohort (12 vaccinees and 4 placebo recipients). B1 cohort will be immunized with 25-fold lower than the OVD in EU (Europe) Phase 1 trial (2x10^9CFU). Cohorts B2 and B3 will be given higher doses in 5-fold increments, and thus cohort B2 will receive 1x10^10 CFU and cohort B3 will receive the OVD in EU Phase 1 trial (5x10^10 CFU). Cohort C1 will be vaccinated with 25-fold lower than the OVD in group B. Cohorts C2 and C3 will receive higher doses in 5-fold increments. Cohort D1 will be given 25- fold lower than the OVD in group C. Cohorts D2 and D3 will receive higher doses in 5-fold increments.
Recruitment, screening, and consenting of the participants will take place at the urban field site of icddr,b in Mirpur. In each cohort, the first dose and immediate safety evaluation will be conducted at the Clinical Trial Unit (CTU), an inpatient facility, where the participants will be closely monitored for 24 hours post-vaccination. If the initial dose is deemed safe, all participants will return to the CTU to receive the second and third time vaccine or placebo on an outpatient basis. Follow-up visits will take place 7 days after each dosing and 28 days after last dosing at the Mirpur field office.
Primary safety endpoint:
- Solicited reactogenicity
- Unsolicited adverse event (AE)
- Serious adverse event (SAE)
Secondary immunogenicity endpoints:
- Changes of antibody responses to antigens from baseline to each visit after vaccination:
- Antibody responses IgG (Immunglobulin G) and IgA (Immunglobulin A) in all age groups in serum
- IgA in lymphocyte supernatant (ALS) and fecal extract
- Functional antibodies:
- ETEC toxins neutralization titers
- Serum bactericidal activity
- Inhibition of bacterial adherence and entry to human colon epithelial cells
- Antibody responses to Shigella and ETEC proteins and peptides
- Antibody avidity against LT, ST and selected Shigella antigens
Secondary shedding endpoint:
Intestinal replication of the ShigETEC vaccine
- Conditions
- Healthy Volunteers
- Being tested
- ShigETEC live, attenuated, oral vaccine, Placebo
- Keywords
- Shigella, Enterotoxigenic Escherichia Coli
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShigETEC live, attenuated, oral vaccineBiological
Vaccine will be delivered orally.
Stage 1:
Adults (18-45 years) will intake the vaccine 3 times 14 days apart in a dose escalating setting with two different doses.
Stage 2:
Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the vaccine 3 times 14 days apart in a dose escalating setting with three different doses.
PlaceboOther
Placebo will be delivered orally.
Stage 1:
Adults (18-45 years) will intake the placebo 3 times 14 days apart
Stage 2:
Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the placebo 3 times 14 days apart.
| Study group | Role | What they receive |
|---|---|---|
| ShigETEC vaccine | Experimental | The vaccine will consist of a suspension of a live, attenuated Shigella bacterial strain (a clinical isolate of Shigella flexneri 2457T strain) into which the genes for nontoxic forms of the ETEC heatlabile toxin B subunit (LTB) and a mutant heat stable toxin (STm) have been inserted. Receives: Biological: ShigETEC live, attenuated, oral vaccine |
| Placebo | Placebo comparator | A saline solution with corn starch Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity
Solicited adverse events in participants after vaccination. ShigETEC vaccine may result in symptoms similar to infection with Shigella or ETEC including fever, decreased appetite, irritability, decreased activity, abdominal pain, nausea, vomiting, loose stool, diarrhoea, dysentery, bloating, excess flatulence and constipation.
Measured: 72 hours after vaccination
Unsolicited adverse event (AE)
Any untoward medical occurrence in study participants during the conduct of a clinical trial, for which there is no or less possibility that the drug caused the event.
Measured: From first vaccination throughout 56 days
Serious adverse event (SAE)
Adverse event(s) classified as serious per definition.
Measured: From first vaccination throughout 56 days
Secondary outcomes (7)
Antigen-specific Antibody titers induced by ShigETEC
Changes in IgG and IgA in plasma/serum, IgA in ALS and fecal extract to specific antigens from baseline to each visit after vaccination.
Measured: From the day of first vaccination throughout 56 days in a 14 day interval
Functional antibodies induced by ShigETEC- neutralization
ETEC toxins neutralization titers
- Serum bactericidal activity
- Inhibition of bacterial adherence and entry to human colon epithelial cells
Measured: From the day of first vaccination throughout 56 days in a 14 day interval
Characterization of the antibody repertoire induced by ShigETEC
Mapping of the vaccine-induced antibody for the entire Shigella proteome and ETEC toxin by high-resolution peptide and protein microarray assay.
Measured: From the day of first vaccination throughout 56 days in a 14 day interval
Antibody avidity induced by ShigETEC
Antigen-antibody binding avidity
Measured: From the day of first vaccination throughout 56 days in a 14 day interval
Shedding of vaccine in stool
Assessment of intestinal replication of the ShigETEC vaccine
Measured: From the day of first vaccination throughout 56 days
Functional antibodies induced by ShigETEC - SBA
Serum bactericidal activity
Measured: From the day of first vaccination throughout 56 days in a 14 day interval
Functional antibodies induced by ShigETEC - adherence
Inhibition of bacterial adherence and entry to human colon epithelial cells
Measured: From the day of first vaccination throughout 56 days in a 14 day interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start26 Nov 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eveliqure Biotechnologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987488
- Sponsor's protocol ID
- PR-19067
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Development of a Live, Attenuated Combination Vaccine Against Shigella and ETEC Diarrhoea: Phase 1b Clinical Trial of ShigETEC Vaccine in Bangladeshi Adults and Three Paediatric Age Groups
- ClinicalTrials.gov ID
- NCT05987488
- Acronym / sponsor ID
- PR-19067
- Conditions
- Healthy Volunteers
- Keywords
- Shigella, Enterotoxigenic Escherichia Coli
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Eveliqure Biotechnologies GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 14 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.
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months).
The main question[s] it aims to answer are:
- Safety and clinical tolerability of the vaccine
- Immune responses generated by the vaccine In the age-descending dose-escalating study
- Adult participants will be divided into 2 escalating dose cohorts
- Each age group of paediatric participants will be divided into 3 escalating dose cohorts
- Participants in each cohort will receive three doses of vaccine/placebo two weeks apart
- Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be monitored after each vaccination dose
- Stool samples will be collected for immunological analysis and shedding of vaccine strain
- Blood samples will be collected for immunological analysis
Detailed description
A double-blind, randomized, placebo-controlled, age-descending and dose-escalating phase 1b clinical trial will be carried out in Bangladeshi adults and three paediatric age groups to evaluate the safety, clinical tolerance, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine.
Objectives of the study
Primary Objectives:
To evaluate the safety and clinical tolerability of oral ShigETEC vaccine in Bangladeshi adults and different age groups of paediatric participants by monitoring the occurrence and severity of clinical signs and symptoms after administration of each of the three vaccinations.
Secondary Objectives:
- To evaluate the immune response to Shigella and ETEC (Enterotoxigenic Escherichia coli) antigens in blood and stool following administration of ShigETEC vaccine.
- To assess the fecal shedding of ShigETEC following ingestion.
The age-descending study will start testing the vaccine in healthy adults (aged 18-45 years) and move subsequently into three different paediatric age groups (aged 2-5 years, 12-23 months and 6-11 months). In the adult participants (group A), fifty-four participants will be enrolled and divided into 3 escalating dose cohorts. Each cohort of 18 healthy adults (12 vaccinees and 6 placebo recipients) will be randomized to receive three times vaccine/placebo two weeks apart. The first adult cohort (cohort A1) will receive the optimal vaccine dose (OVD) found in Phase I Europe trial (5x10^10 CFU). Cohort A2 will be given 4-fold higher dose than cohort A1 (2x10^11 CFU). Cohort A3 will receive a lower dose according to DSMB decision (2x10^9 CFU).
In each of the 2-5 years (group B), 12-23 months (group C), and 6-11 months age group (group D), 48 participants will be enrolled and divided into 3 escalating dose cohorts with 16 participants in each cohort (12 vaccinees and 4 placebo recipients). B1 cohort will be immunized with 25-fold lower than the OVD in EU (Europe) Phase 1 trial (2x10^9CFU). Cohorts B2 and B3 will be given higher doses in 5-fold increments, and thus cohort B2 will receive 1x10^10 CFU and cohort B3 will receive the OVD in EU Phase 1 trial (5x10^10 CFU). Cohort C1 will be vaccinated with 25-fold lower than the OVD in group B. Cohorts C2 and C3 will receive higher doses in 5-fold increments. Cohort D1 will be given 25- fold lower than the OVD in group C. Cohorts D2 and D3 will receive higher doses in 5-fold increments.
Recruitment, screening, and consenting of the participants will take place at the urban field site of icddr,b in Mirpur. In each cohort, the first dose and immediate safety evaluation will be conducted at the Clinical Trial Unit (CTU), an inpatient facility, where the participants will be closely monitored for 24 hours post-vaccination. If the initial dose is deemed safe, all participants will return to the CTU to receive the second and third time vaccine or placebo on an outpatient basis. Follow-up visits will take place 7 days after each dosing and 28 days after last dosing at the Mirpur field office.
Primary safety endpoint:
- Solicited reactogenicity
- Unsolicited adverse event (AE)
- Serious adverse event (SAE)
Secondary immunogenicity endpoints:
- Changes of antibody responses to antigens from baseline to each visit after vaccination:
- Antibody responses IgG (Immunglobulin G) and IgA (Immunglobulin A) in all age groups in serum
- IgA in lymphocyte supernatant (ALS) and fecal extract
- Functional antibodies:
- ETEC toxins neutralization titers
- Serum bactericidal activity
- Inhibition of bacterial adherence and entry to human colon epithelial cells
- Antibody responses to Shigella and ETEC proteins and peptides
- Antibody avidity against LT, ST and selected Shigella antigens
Secondary shedding endpoint:
Intestinal replication of the ShigETEC vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShigETEC vaccine | Experimental | Biological: ShigETEC live, attenuated, oral vaccineThe vaccine will consist of a suspension of a live, attenuated Shigella bacterial strain (a clinical isolate of Shigella flexneri 2457T strain) into which the genes for nontoxic forms of the ETEC heatlabile toxin B subunit (LTB) and a mutant heat stable toxin (STm) have been inserted. |
| Placebo | Placebo comparator | Other: PlaceboA saline solution with corn starch |
Who may qualify
- Ages
- 6 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female adults, children, toddlers, and infants aged between 18-45 years, 2-5 years, 12-23 months, and 6-11 months, respectively at the time of vaccination.
- Free of obvious health problems as determined by medical history and clinical examination before entering into the study.
- Normal bowel habits.
- Informed consent form signed.
- Negative pregnancy tests before each vaccination for females of childbearing potential. Adult participants agree to use birth control steps or abstinence.
Key exclusion criteria (14 listed)
- Nursing and breast-feeding women.
- Presence of any known significant medical or psychiatric condition / systemic disorder.
- History of congenital abdominal disorders, intussusception, abdominal surgery, any other congenital disorder, any neurologic disorders or seizures.
- Clinically significant abnormalities in screening hematology, serum chemistry.
- Known or suspected HIV, hepatitis infection.
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 |
|---|---|---|
| ShigETEC live, attenuated, oral vaccineVaccine will be delivered orally. Stage 1: Adults (18-45 years) will intake the vaccine 3 times 14 days apart in a dose escalating setting with two different doses. Stage 2: Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the vaccine 3 times 14 days apart in a dose escalating setting with three different doses. | Biological | ShigETEC vaccine |
| PlaceboPlacebo will be delivered orally. Stage 1: Adults (18-45 years) will intake the placebo 3 times 14 days apart Stage 2: Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the placebo 3 times 14 days apart. | Other | Placebo |
Primary outcome
Reactogenicity
Time frame: 72 hours after vaccination
Solicited adverse events in participants after vaccination. ShigETEC vaccine may result in symptoms similar to infection with Shigella or ETEC including fever, decreased appetite, irritability, decreased activity, abdominal pain, nausea, vomiting, loose stool, diarrhoea, dysentery, bloating, excess flatulence and constipation.
Unsolicited adverse event (AE)
Time frame: From first vaccination throughout 56 days
Any untoward medical occurrence in study participants during the conduct of a clinical trial, for which there is no or less possibility that the drug caused the event.
Serious adverse event (SAE)
Time frame: From first vaccination throughout 56 days
Adverse event(s) classified as serious per definition.
7 secondary outcomes
Antigen-specific Antibody titers induced by ShigETEC
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Functional antibodies induced by ShigETEC- neutralization
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Characterization of the antibody repertoire induced by ShigETEC
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Antibody avidity induced by ShigETEC
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Shedding of vaccine in stool
Time frame: From the day of first vaccination throughout 56 days
Functional antibodies induced by ShigETEC - SBA
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Functional antibodies induced by ShigETEC - adherence
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
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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 ShigETEC live, attenuated, oral vaccine in people with Healthy Volunteers, run by Eveliqure Biotechnologies GmbH at 1 site in Bangladesh.
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 23 Jan 2026. 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 Bangladesh. 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?
Reactogenicity (time frame: 72 hours after vaccination). The study lists 3 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 23 Jan 2026.