Herpes ZosterPhase 1NCT05750017
A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine
A Phase 1 study testing Low Dose Recombinant Herpes Zoster Vaccine (LZ901) and High Dose Recombinant Herpes Zoster Vaccine (LZ901) in people with Herpes Zoster and Vaccine-Preventable Diseases, run by Beijing Luzhu Biotechnology Co., Ltd. at 1 site in United States.
Trial summary
This clinical trial is to study the safety and tolerability of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase I, randomized, double-blind, placebo-controlled, dose escalation study in healthy people aged 50 to 70 years inclusive. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Vaccine-Preventable Diseases
- What is being tested?
- Low Dose Recombinant Herpes Zoster Vaccine (LZ901) and High Dose Recombinant Herpes Zoster Vaccine (LZ901)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 15 Mar 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females able to provide legal identity certificate, aged 50 to 70 years inclusive at the time of signing the ICF;
- Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF;
- Subjects are healthy or have well controlled mild medical conditions as determined by the investigator；
- Female subjects are not pregnant or lactating. Female subjects with childbearing potential* should take reliable contraceptive measures**, and have no pregnancy and fertility plan within 7 months;
- Female subjects of childbearing potential are defined as sexually mature women: 1) have not undergone hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; 2) have had natural menses at any time in the preceding 12 consecutive months (without an alternative medical cause). Post-menopausal should be confirmed with FSH and Estradiol levels.
- Reliable, medically acceptable forms of contraception:
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- For 3 months prior to screening - hormonal contraceptive (e.g., oral, patch, injectable, depot or vaginal ring), or implantable device (implantable rod or intrauterine device), or
- For at least 1 month prior to screening - a double barrier method (e.g., diaphragm, cervical cap, or condom in conjunction with spermicide or sponge), or
- Subjects of reproductive age that are abstinent are acceptable provided they agree to a double barrier method should they become sexually active during the study.
- and subjects agree to continue birth control for at least 7 months.
- Able to attend all scheduled follow-up visits and able to comply with protocol requirements;
- Oral temperature < 37.5℃/99.5℉.
Who cannot join
- Subjects with a personal history or family history of convulsion, epilepsy, encephalopathy, and psychosis;
- Subjects who received immunosuppressive therapy within 3 months before vaccination (e.g., long-term use of systemic glucocorticoids for ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalence);
- Allergic to any component of the investigational vaccine, or have a history of a severe allergy to any vaccination;
- Impaired immune function or diagnosed with congenital or acquired immunodeficiency disease, positive serology for Hepatitis B Surface Antigen, Hepatitis C Antibody and human immunodeficiency virus (HIV);
- History of varicella or herpes zoster vaccination;
- History of HZ;
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- Received an inactivated or recombinant vaccine within 14 days or any live vaccine within 28 days prior to vaccination;
- Subjects who have acute diseases within 3 days before vaccination, or acute stage or exacerbation of chronic diseases within 1 month before vaccination;
- Subjects with tattoos to the upper arm deltoid area or have infectious skin disease;
- History of thrombocytopenia or other coagulation disorders, which may cause contraindications to intramuscular injection;
- History of asplenia or functional asplenia, and asplenia or splenectomy due to any condition;
- Subjects with ≥ Grade 2 laboratory abnormalities and Grade 1 laboratory abnormalities that the investigator consider clinically significant;
- Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical studies before the end of this clinical study;
- Any conditions that in the opinion of the investigator may affect subject safety or assessments (disease factors such as extensive psoriasis, unexplained skin rash, eczema, chronic pain syndrome, or social factors such as plans to move elsewhere before the end of the study).
- A positive screen for alcohol, drugs of abuse at screening period and Day 0 (before vaccination).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
Frank Lee, MD, 201-416-7745 ext. (201) 416-7753, flee@frontagelab.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine (LZ901) in Subjects Aged 50 to 70 Years Inclusive
This clinical trial is to study the safety and tolerability of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase I, randomized, double-blind, placebo-controlled, dose escalation study in healthy people aged 50 to 70 years inclusive. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 66 participators who will receive two-dose injection at the upper arm.
LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide.
Read more
In this study:
- The participation is voluntary.
- Before the study, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this study.
- The study vaccine is LZ901 with two different dose levels (50μg/0.5 mL, 100μg/0.5 mL). The placebo, which is saline solution, has no active drug. Participants will receive one of three as above mentioned.
- Participants will be enrolled in one of four cohorts. If participants are enrolled in Cohorts 1 or 2, they will receive LZ901. If participants are enrolled in Cohorts 3 or 4, they will have a 2 out of 3 chance (66%) of receiving LZ901 and 1 out of 3 chance (33%) of receiving placebo.
- In Cohort 3 and 4, the study staff and participants will not know which study treatment participants will be receiving. However, the study doctor can get this information in case of an emergency.
- Participants will stay at the clinic for 30 minutes after each vaccination to observe if there are any uncomfortable.
- This study will last about 8 months and will include about 8 study visits to the clinic. During this period, participants will receive a follow-up phone call and/or email by the study staff to follow the condition closely for safety, and record on diary/contact card.
- Participants will receive some tests during the study, include safety tests such as physical examination, vital signs measurements, blood tests, urinalysis. Participants will be measured the levels of specific antibodies to see if the vaccine works well.
This study is for research purposes only. Participants may not receive any direct benefits from participating in this study but have a chance to be in a study that may help others in the future.
- Conditions
- Herpes Zoster, Vaccine-Preventable Diseases
- Being tested
- Low Dose Recombinant Herpes Zoster Vaccine (LZ901), High Dose Recombinant Herpes Zoster Vaccine (LZ901), Placebo
- Keywords
- Herpes Zoster, Vaccine
- Medical subject headings
- Herpes Zoster, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Recombinant Herpes Zoster Vaccine (LZ901)Biological
0.5 mL per dose, containing a total of 50 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant.
High Dose Recombinant Herpes Zoster Vaccine (LZ901)Biological
0.5 mL per dose, containing a total of 100 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant.
PlaceboDrug
Also called Saline solution
0.5 mL per dose, containing 4.5 mg sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1: Low dose sentinel group | Experimental | Three subjects will be first enrolled into low dose sentinel group in open-label, prior to initiation of dosing in each dose level main group. Receives: Biological: Low Dose Recombinant Herpes Zoster Vaccine (LZ901) |
| Cohort2: High dose sentinel group | Experimental | After reviewing the safety through 7 days after the first dose of LZ901, if no safety signals occur, another 3 subjects will be enrolled into high dose sentinel group in open-label. Receives: Biological: High Dose Recombinant Herpes Zoster Vaccine (LZ901) |
| Cohort3: Low dose main group | Placebo comparator | If also no safety signals occur through 7 days after the first dose of LZ901 in high dose sentinel group, 30 subjects will be randomized in a 2:1 ratio to receive two doses of LZ901 or placebo in a double-blind fashion in low dose main group. Receives: Biological: Low Dose Recombinant Herpes Zoster Vaccine (LZ901); Drug: Placebo |
| Cohort4: High dose main group | Placebo comparator | Subjects will be enrolled in high dose main group also after the safety review through 7 days after the first dose of LZ901 or placebo in low dose main group. Receives: Biological: High Dose Recombinant Herpes Zoster Vaccine (LZ901); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited AEs
A solicited AE is a pre-specified outcome that the subject is asked to record as present or not.
The solicited AEs can be classified as vaccination site (local) AEs and Solicited systemic AEs based on the occurrence site.
Measured: From Day 0 through Day 6 after each vaccination.
Unsolicited AEs
Unsolicited AEs include all AEs, except solicited AEs reported Days 0~6 after the study intervention.
Measured: From Days 0~29 after each vaccination.
AEs leading to withdrawal
The incidence of AEs leading subjects to withdrawal according to criteria for subject treatment discontinuation and withdrawal from study.
Measured: From Day 0 until the outcome is clear after the following up, up to the end of study.
SAEs and MAAEs
The incidence of all serious adverse events (SAEs) and medically attended adverse events (MAAEs).
Measured: From Day 0 through 6 months after the full course vaccination.
Abnormal laboratory tests results
The incidence of abnormal laboratory tests results.
Measured: On Day 3 (+ 1 day) after each study intervention.
Secondary outcomes (7)
The seropositivity rate of anti-gE antibody
The percentage of seropositive subjects of anti-gE antibody.
Measured: On Day 30 after each study intervention.
The seropositivity rate of anti-VZV antibody
The percentage of seropositive subjects of anti-VZV antibody.
Measured: On Day 30 after each study intervention.
Geometric mean concentration (GMC) of anti-gE
Measured by ELISA.
Measured: On Day 30 after each study intervention.
Geometric mean titer (GMT) of anti-VZV
Measured by fluorescent antibody to the membrane antigen (FAMA).
Measured: On Day 30 after each study intervention.
The seroconversion rate of anti-VZV antibody
Seroconversion refers to at least a 4-fold increase in the anti-VZV antibody titer at the endpoint as compared to the prevaccination concentration (for subjects seropositive pre-vaccination) or a 4-fold increase at the endpoint as compared to the anti-VZV antibody titer cut-off value for seropositivity (for subjects seronegative pre-vaccination).
Measured: On Day 30 after each study intervention.
The seroconversion rate of anti-gE antibody
Seroconversion refers to at least a 4-fold increase in the anti-gE Ab concentration at the endpoint as compared to the prevaccination concentration (for subjects seropositive pre-vaccination) or a 4-fold increase at the endpoint as compared to the anti-gE Ab cut-off value for seropositivity (for subjects seronegative pre-vaccination).
Measured: On Day 30 after each study intervention.
Change of anti-Fc antibody
Change of anti-Fc antibody on Day 30 after each study intervention compared with pre-immunization.
Measured: From pre-immunization to Day 30 after each study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start23 Mar 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Luzhu Biotechnology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750017
- Sponsor's protocol ID
- LZ901-1
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine (LZ901) in Subjects Aged 50 to 70 Years Inclusive
- ClinicalTrials.gov ID
- NCT05750017
- Acronym / sponsor ID
- LZ901-1
- Conditions
- Herpes Zoster, Vaccine-Preventable Diseases
- Keywords
- Herpes Zoster, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Beijing Luzhu Biotechnology Co., Ltd.University, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 1 Mar 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.
This clinical trial is to study the safety and tolerability of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase I, randomized, double-blind, placebo-controlled, dose escalation study in healthy people aged 50 to 70 years inclusive. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 66 participators who will receive two-dose injection at the upper arm.
LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide.
In this study:
- The participation is voluntary.
- Before the study, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this study.
- The study vaccine is LZ901 with two different dose levels (50μg/0.5 mL, 100μg/0.5 mL). The placebo, which is saline solution, has no active drug. Participants will receive one of three as above mentioned.
- Participants will be enrolled in one of four cohorts. If participants are enrolled in Cohorts 1 or 2, they will receive LZ901. If participants are enrolled in Cohorts 3 or 4, they will have a 2 out of 3 chance (66%) of receiving LZ901 and 1 out of 3 chance (33%) of receiving placebo.
- In Cohort 3 and 4, the study staff and participants will not know which study treatment participants will be receiving. However, the study doctor can get this information in case of an emergency.
- Participants will stay at the clinic for 30 minutes after each vaccination to observe if there are any uncomfortable.
- This study will last about 8 months and will include about 8 study visits to the clinic. During this period, participants will receive a follow-up phone call and/or email by the study staff to follow the condition closely for safety, and record on diary/contact card.
- Participants will receive some tests during the study, include safety tests such as physical examination, vital signs measurements, blood tests, urinalysis. Participants will be measured the levels of specific antibodies to see if the vaccine works well.
This study is for research purposes only. Participants may not receive any direct benefits from participating in this study but have a chance to be in a study that may help others in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort1: Low dose sentinel group | Experimental | Biological: Low Dose Recombinant Herpes Zoster Vaccine (LZ901)Three subjects will be first enrolled into low dose sentinel group in open-label, prior to initiation of dosing in each dose level main group. |
| Cohort2: High dose sentinel group | Experimental | Biological: High Dose Recombinant Herpes Zoster Vaccine (LZ901)After reviewing the safety through 7 days after the first dose of LZ901, if no safety signals occur, another 3 subjects will be enrolled into high dose sentinel group in open-label. |
| Cohort3: Low dose main group | Placebo comparator | Biological: Low Dose Recombinant Herpes Zoster Vaccine (LZ901), Drug: PlaceboIf also no safety signals occur through 7 days after the first dose of LZ901 in high dose sentinel group, 30 subjects will be randomized in a 2:1 ratio to receive two doses of LZ901 or placebo in a double-blind fashion in low dose main group. |
| Cohort4: High dose main group | Placebo comparator | Biological: High Dose Recombinant Herpes Zoster Vaccine (LZ901), Drug: PlaceboSubjects will be enrolled in high dose main group also after the safety review through 7 days after the first dose of LZ901 or placebo in low dose main group. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females able to provide legal identity certificate, aged 50 to 70 years inclusive at the time of signing the ICF;
- Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF;
- Subjects are healthy or have well controlled mild medical conditions as determined by the investigator；
- Female subjects are not pregnant or lactating. Female subjects with childbearing potential* should take reliable contraceptive measures**, and have no pregnancy and fertility plan within 7 months;
- Female subjects of childbearing potential are defined as sexually mature women: 1) have not undergone hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; 2) have had natural menses at any time in the preceding 12 consecutive months (without an alternative medical cause). Post-menopausal should be confirmed with FSH and Estradiol levels.
Key exclusion criteria (15 listed)
- Subjects with a personal history or family history of convulsion, epilepsy, encephalopathy, and psychosis;
- Subjects who received immunosuppressive therapy within 3 months before vaccination (e.g., long-term use of systemic glucocorticoids for ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalence);
- Allergic to any component of the investigational vaccine, or have a history of a severe allergy to any vaccination;
- Impaired immune function or diagnosed with congenital or acquired immunodeficiency disease, positive serology for Hepatitis B Surface Antigen, Hepatitis C Antibody and human immunodeficiency virus (HIV);
- History of varicella or herpes zoster vaccination;
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 |
|---|---|---|
| Low Dose Recombinant Herpes Zoster Vaccine (LZ901)0.5 mL per dose, containing a total of 50 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant. | Biological | Cohort1: Low dose sentinel group, Cohort3: Low dose main group |
| High Dose Recombinant Herpes Zoster Vaccine (LZ901)0.5 mL per dose, containing a total of 100 µg recombinant herpes zoster virus glycoprotein E, adjuvanted with alumina adjuvant. | Biological | Cohort2: High dose sentinel group, Cohort4: High dose main group |
| PlaceboAlso: Saline solution0.5 mL per dose, containing 4.5 mg sodium chloride. | Drug | Cohort3: Low dose main group, Cohort4: High dose main group |
Primary outcome
Solicited AEs
Time frame: From Day 0 through Day 6 after each vaccination.
A solicited AE is a pre-specified outcome that the subject is asked to record as present or not. The solicited AEs can be classified as vaccination site (local) AEs and Solicited systemic AEs based on the occurrence site.
Unsolicited AEs
Time frame: From Days 0~29 after each vaccination.
Unsolicited AEs include all AEs, except solicited AEs reported Days 0~6 after the study intervention.
AEs leading to withdrawal
Time frame: From Day 0 until the outcome is clear after the following up, up to the end of study.
The incidence of AEs leading subjects to withdrawal according to criteria for subject treatment discontinuation and withdrawal from study.
SAEs and MAAEs
Time frame: From Day 0 through 6 months after the full course vaccination.
The incidence of all serious adverse events (SAEs) and medically attended adverse events (MAAEs).
Abnormal laboratory tests results
Time frame: On Day 3 (+ 1 day) after each study intervention.
The incidence of abnormal laboratory tests results.
7 secondary outcomes
The seropositivity rate of anti-gE antibody
Time frame: On Day 30 after each study intervention.
The seropositivity rate of anti-VZV antibody
Time frame: On Day 30 after each study intervention.
Geometric mean concentration (GMC) of anti-gE
Time frame: On Day 30 after each study intervention.
Geometric mean titer (GMT) of anti-VZV
Time frame: On Day 30 after each study intervention.
The seroconversion rate of anti-VZV antibody
Time frame: On Day 30 after each study intervention.
The seroconversion rate of anti-gE antibody
Time frame: On Day 30 after each study intervention.
Change of anti-Fc antibody
Time frame: From pre-immunization to Day 30 after each study intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
Frank Lee, MD principal investigator
Frontage Clinical Services, Inc.
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 Low Dose Recombinant Herpes Zoster Vaccine (LZ901) and High Dose Recombinant Herpes Zoster Vaccine (LZ901) in people with Herpes Zoster and Vaccine-Preventable Diseases, run by Beijing Luzhu Biotechnology Co., Ltd. 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 12 inclusion and 15 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 27 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Lee, MD ((201) 416-7745 ext. (201) 416-7753, flee@frontagelab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited AEs (time frame: From Day 0 through Day 6 after each vaccination.). The study lists 5 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 27 Mar 2023.