Herpes ZosterPhase 2NCT07205796
A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
A Phase 2 study testing HZ Vaccine (IN001) and Shingrix in people with Herpes Zoster, run by Shenzhen Shenxin Biotechnology Co., Ltd.
Trial summary
The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 79 years of age. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- HZ Vaccine (IN001) and Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults, of any race or ethnicity, between 50 and 79 years of age, inclusive, at Screening.
- Male and female participants must have a body mass index between 18.5 and 34.9 kg/m^2, inclusive, at Screening, and body weight ≥ 50 kg for males and ≥ 45 kg for females.
- Participants must be able to freely provide documented informed consent prior to study procedures being performed.
- Participants must be in good general health as determined by comprehensive evaluation by Investigators at the time of enrollment.
- Participants with asymptomatic medical conditions that are not associated with end-organ damage may be include provided that they are being appropriately treated as per standard of care, are clinically stable, and are not receiving treatments what would be exclusionary in the opinion of the Investigator.
- Participants must be able and agree to comply with all study visits and procedures (including blood tests, diary completion, receipt of telephone calls from the site, willingness to be available for unscheduled clinic visits).
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- Females of reproductive age will not be pregnant or lactating.
- Females of childbearing potential, who are sexually active and at risk for pregnancy with their partner(s), must have used appropriate method of contraception at least 30 days prior to enrollment and agree to use a highly effective method of contraception consistently and correctly from enrollment to Study Day 236 (6 months after second vaccination). The Investigator or designee, in consultation with the participant, will confirm that the participant has selected an appropriate method of contraception for the individual participant and his or her partner from the list of appropriate contraception methods and will confirm that the participant has been instructed in its consistent and correct use.
- Participants must be willing to refrain from blood donation throughout study participation.
Who cannot join
- Participants with a known history of HZ.
- Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.
- Participants with a known history of severe heart disease (i.e., heart failure, recent coronary artery disease, myocarditis, pericarditis, or cardiomyopathy).
- Participants with acute medical illness or febrile illness, including oral temperature ≥ 38.0°C (≥ 100.4°F) within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after the fever and/or acute illness has been resolved.
- Participants with any medical, neurological, or psychiatric condition that, in the opinion of the Investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
- Participants with a known history of hypersensitivity reactions including anaphylaxis and urticaria, or other significant adverse reactions to IN001 or its excipients; or participants with a known history of severe allergic reaction (e.g., anaphylaxis) to any mRNA vaccine (e.g., COVID-19 mRNA vaccine, RSV mRNA vaccine), any component of SHINGRIX^TM, or after a previous dose of SHINGRIX^TM.
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- Participants who have a positive pregnancy test at the screening visit or who intend to become pregnant during or breastfeed through Study Day 236 (6 months after second vaccination).
- Participants with uncontrolled hypertension (supine systolic blood pressure [BP] > 140 mmHg or supine average diastolic BP > 90 mmHg at Screening). Eligibility may be reassessed with a single repeat measurement at the Investigator's discretion, and the repeat value will be used for determination.
- Participants with a history of significant hematologic abnormalities or history of thrombosis with thrombocytopenia syndrome.
- Participants with hematology and/or clinical chemistry laboratory result(s) that meet the definition of a Grade ≥ 2 abnormality as delineated in the FDA guidance. However, if the institutional normal reference ranges differ from those defined by the region or site, exceptions may be considered on a case-by-case basis with the agreement of the Investigator and the Sponsor.
- Participants with a history of congenital or acquired immunodeficiency.
- Participants with an immunosuppressive or immunodeficient state, asplenia, or recurrent severe infections.
- Participants with a known history of chronic infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis.
- Positive HBV and HCV panel and/or positive HIV test. Participants whose results are compatible with prior immunization (indicating evidence of protection) may be included at the discretion of the Investigator that take into account factors such as the timing and effectiveness of the previous immunization.
- Participants with positive syphilis test.
- Participants with chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial participation or interpretation of study results.
- Participants with a known history of vaccination against varicella or HZ.
- Participants who have received immunoglobulins and/or any blood or blood products within 4 months before the first study vaccination or who plan to receive such products at any time during the study.
- Participants who have received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 3 months of Screening (or 5 half-lives, whichever is longer) or who plan to receive them across the duration of the study.
- Participants requiring systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for ≥ 10 days within 30 days of Screening. The use of topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
- Participants who have received or plan to receive any licensed vaccine ≤ 28 days prior to the first vaccination (Day 0) or who plan to receive a licensed vaccine ≤ 28 days after the first study vaccination or ≤ 28 days before or after the second study vaccination. The only exception is licensed inactivated influenza vaccine or non-replicating influenza vaccine, which may be given ≥ 14 days before or ≥ 28 days after receipt the first or second study vaccination.
- Participants receiving treatment with another investigational drug, biological agent, or device ≤ 28 days of Screening, or 5 half-lives of the investigational drug, whichever is longer; or currently enrolled in or plans to participate in another clinical trial with an investigational agent during the study period (including the follow-up period of the study).
- Participants with history of drug abuse within 1 year prior to Screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to Screening.
- History of alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months prior to Screening that exceeds 10 units for women or 15 units for men of alcohol per week.
- Positive alcohol breath test result or positive urine drug screen (UDS) caused by misuse of soft drugs, hard drugs or abuse of any other concomitant medications at Screening and/or on Study Day 0.
- Participants who are Investigator site staff members, employees of the Sponsor or the clinical research organization directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals.
- Participants with a demonstrated inability to comply with the study procedures.
- Anything that the Investigator considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Randomized, Multicenter, Active-controlled, Double-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a 2-dose Regimen of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 79 Years Old
The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 79 years of age.
- Conditions
- Herpes Zoster
- Being tested
- HZ Vaccine (IN001), Shingrix
- Keywords
- IN001, mRNA Vaccine, Vaccine, Varicella-zoster Virus, VZV, Viral Diseases, Shingles, Messenger RNA, Herpes Zoster (HZ), Skin Diseases, Infectious, Safety, Reactogenicity, Immunogenicity, Innorna, Shenxin, Herpesviridae Infections, DNA Virus Infections, Infections, Varicella Zoster Virus Infection, Skin Diseases, Viral
- Medical subject headings
- Herpes Zoster, Chickenpox, Virus Diseases, Skin Diseases, Infectious, Herpesviridae Infections, DNA Virus Infections, Infections, Varicella Zoster Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HZ Vaccine (IN001)Biological
Formulation for injection
ShingrixBiological
Sterile suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| IN001 Dose A (Arm 1) | Experimental | Participants will receive IN001 at dose level A by IM injection on Day 0 and Day 56. Receives: Biological: HZ Vaccine (IN001) |
| IN001 Dose B (Arm 2) | Experimental | Participants will receive IN001 at dose level B by IM injection on Day 0 and Day 56. Receives: Biological: HZ Vaccine (IN001) |
| IN001 Dose C (Arm 3) | Experimental | Participants will receive IN001 at dose level C by IM injection on Day 0 and Day 56. Receives: Biological: HZ Vaccine (IN001) |
| Shingrix (Arm 4) | Active comparator | Participants will receive Shingrix by IM injection on Day 0 and Day 56. Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: Baseline (before first vaccination); 28 days post-second vaccination
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA
Measured: 28 days post-second vaccination
Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Measured: Baseline (before first vaccination); 28 days post-second vaccination
Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Measured: 28 days post-second vaccination
Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA
Measured: 28 days post-second vaccination
Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Measured: 28 days post-second vaccination
Percentage of Participants Reporting Solicited Local Reactions
Measured: For 14 days after each vaccination
Percentage of Participants Reporting Solicited Systemic Events
Measured: For 14 days after each vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs)
Measured: For 28 days after each vaccination
Percentage of Participants With Any Medically Attended AEs (MAAEs)
Measured: From the first vaccination to 6 months after the second vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal
Measured: From the first vaccination to 12 months after the second vaccination
Secondary outcomes (8)
GMC of Anti-gE Antibodies as Measured by ELISA
Measured: Baseline (before first vaccination); 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
Change from Baseline in GMFR of Anti-gE Antibodies as Measured by ELISA
Measured: 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
GMT of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Measured: Baseline (before first vaccination); 56 days post-first vaccination; 6 and 12 months post-second vaccination
Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Measured: 56 days post-first vaccination; 6 and 12 months post-second vaccination
Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA
Measured: 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Measured: 56 days post-first vaccination; 6 and 12 months post-second vaccination
gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot)
Measured: Baseline (before first vaccination); 28 and 56 days post-first vaccination; 28 days and 3, 6 and 12 months post-second vaccination
Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS)
Measured: Baseline (before first vaccination); 56 days post-first vaccination; 14 and 28 days post-second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 May 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Shenxin Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205796
- Sponsor's protocol ID
- IN001005
- Status last verified
- Oct 2025
- First submitted
- 26 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Multicenter, Active-controlled, Double-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a 2-dose Regimen of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 79 Years Old
- ClinicalTrials.gov ID
- NCT07205796
- Acronym / sponsor ID
- IN001005
- Conditions
- Herpes Zoster
- Keywords
- IN001, mRNA Vaccine, Vaccine, Varicella-zoster Virus, VZV, Viral Diseases, Shingles, Messenger RNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shenzhen Shenxin Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 3 Oct 2025 (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 study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 79 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IN001 Dose A (Arm 1) | Experimental | Biological: HZ Vaccine (IN001)Participants will receive IN001 at dose level A by IM injection on Day 0 and Day 56. |
| IN001 Dose B (Arm 2) | Experimental | Biological: HZ Vaccine (IN001)Participants will receive IN001 at dose level B by IM injection on Day 0 and Day 56. |
| IN001 Dose C (Arm 3) | Experimental | Biological: HZ Vaccine (IN001)Participants will receive IN001 at dose level C by IM injection on Day 0 and Day 56. |
| Shingrix (Arm 4) | Active comparator | Biological: ShingrixParticipants will receive Shingrix by IM injection on Day 0 and Day 56. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female adults, of any race or ethnicity, between 50 and 79 years of age, inclusive, at Screening.
- Male and female participants must have a body mass index between 18.5 and 34.9 kg/m^2, inclusive, at Screening, and body weight ≥ 50 kg for males and ≥ 45 kg for females.
- Participants must be able to freely provide documented informed consent prior to study procedures being performed.
- Participants must be in good general health as determined by comprehensive evaluation by Investigators at the time of enrollment.
- Participants with asymptomatic medical conditions that are not associated with end-organ damage may be include provided that they are being appropriately treated as per standard of care, are clinically stable, and are not receiving treatments what would be exclusionary in the opinion of the Investigator.
Key exclusion criteria (28 listed)
- Participants with a known history of HZ.
- Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.
- Participants with a known history of severe heart disease (i.e., heart failure, recent coronary artery disease, myocarditis, pericarditis, or cardiomyopathy).
- Participants with acute medical illness or febrile illness, including oral temperature ≥ 38.0°C (≥ 100.4°F) within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after the fever and/or acute illness has been resolved.
- Participants with any medical, neurological, or psychiatric condition that, in the opinion of the Investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
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 |
|---|---|---|
| HZ Vaccine (IN001)Formulation for injection | Biological | IN001 Dose A (Arm 1), IN001 Dose B (Arm 2), IN001 Dose C (Arm 3) |
| ShingrixSterile suspension for injection | Biological | Shingrix (Arm 4) |
Primary outcome
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Baseline (before first vaccination); 28 days post-second vaccination
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA
Time frame: 28 days post-second vaccination
Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: Baseline (before first vaccination); 28 days post-second vaccination
Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: 28 days post-second vaccination
Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA
Time frame: 28 days post-second vaccination
Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: 28 days post-second vaccination
Percentage of Participants Reporting Solicited Local Reactions
Time frame: For 14 days after each vaccination
Percentage of Participants Reporting Solicited Systemic Events
Time frame: For 14 days after each vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs)
Time frame: For 28 days after each vaccination
Percentage of Participants With Any Medically Attended AEs (MAAEs)
Time frame: From the first vaccination to 6 months after the second vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal
Time frame: From the first vaccination to 12 months after the second vaccination
8 secondary outcomes
GMC of Anti-gE Antibodies as Measured by ELISA
Time frame: Baseline (before first vaccination); 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
Change from Baseline in GMFR of Anti-gE Antibodies as Measured by ELISA
Time frame: 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
GMT of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: Baseline (before first vaccination); 56 days post-first vaccination; 6 and 12 months post-second vaccination
Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: 56 days post-first vaccination; 6 and 12 months post-second vaccination
Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA
Time frame: 28 and 56 days post-first vaccination; 14 days and 3, 6 and 12 months post-second vaccination
Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay
Time frame: 56 days post-first vaccination; 6 and 12 months post-second vaccination
gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot)
Time frame: Baseline (before first vaccination); 28 and 56 days post-first vaccination; 28 days and 3, 6 and 12 months post-second vaccination
Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS)
Time frame: Baseline (before first vaccination); 56 days post-first vaccination; 14 and 28 days post-second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HZ Vaccine (IN001) and Shingrix in people with Herpes Zoster, run by Shenzhen Shenxin Biotechnology Co., Ltd.
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 9 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: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development Innorna (+86-755-86532375, cd@innorna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) (time frame: Baseline (before first vaccination); 28 days post-second vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.