Healthy Participants StudyPhase 1NCT07577479

A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants

A Phase 1 study testing BW-50218 Injection and Saline (0.9% NaCl) in people with Healthy Participants Study, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants Study
What is being tested?: BW-50218 Injection and Saline (0.9% NaCl)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteChina
Study dates: 18 May 2026to 30 Apr 2028
Phase: Phase 1
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Capable of providing written informed consent and complying with all study procedures for the duration of the study.
Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
Male participants with partners of childbearing potential must agree to use effective contraception.

Who cannot join

Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
Recent hospitalization or a significant acute medical event.
History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
Positive test for hepatitis B, hepatitis C, or HIV.

Trial locations and contacts

1 site in 1 country.

China1 site

Argo Investigative Site
Shanghai

Other trials in China

About this study

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants

A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants

Read the detailed description

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants

Conditions: Healthy Participants Study
Being tested: BW-50218 Injection, Saline (0.9% NaCl)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BW-50218 InjectionDrug
Solution for injection
Saline (0.9% NaCl)Drug
Solution for injection

Study groups in NCT07577479
Study group	Role	What they receive
BW-50218 Dose1	Experimental	Single dose of BW-50218 injection (Dose 1) Receives: Drug: BW-50218 Injection
BW-50218 Dose 2	Experimental	Single dose of BW-50218 injection (Dose 2) Receives: Drug: BW-50218 Injection
BW-50218 Dose 3	Experimental	Single dose of BW-50218 injection (Dose 3) Receives: Drug: BW-50218 Injection
Saline Placebo	Placebo comparator	Single dose of Saline Placebo Receives: Drug: Saline (0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events. The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).
Measured: From baseline up to Day 360 (End of Study)
Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From baseline up to Day 360 (End of Study)
Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From baseline up to Day 360 (End of Study)
Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From baseline up to Day 360 (End of Study)
Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From baseline up to Day 360 (End of Study)
Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From baseline up to Day 360 (End of Study)
Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be fagged.
Measured: From baseline up to Day 360 (End of Study)
Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
Abnormal physical examination findings will be listed.
Measured: From baseline up to Day 360 (End of Study)
Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Abnormal physical examination findings will be listed.
Measured: From baseline up to Day 360 (End of Study)
Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Abnormal physical examination findings will be listed.
Measured: From baseline up to Day 360 (End of Study)
Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Abnormal physical examination findings will be listed.
Measured: From baseline up to Day 360 (End of Study)
Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
Measured: From baseline up to Day 360 (End of Study)
Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
Measured: From baseline up to Day 360 (End of Study)
Change from Baseline in Physical Examination Findings
Assessment of clinically significant changes in physical examination findings
Measured: From baseline up to Day 360 (End of Study)
Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From baseline up to Day 360 (End of Study)

Secondary outcomes (5)

Maximum Observed Plasma Concentration (Cmax)
Evaluation of the maximum plasma concentration of BW-50218.
Measured: From pre-dose up to Day 8
Time to Maximum Plasma Concentration (Tmax)
Evaluation of the time to reach maximum plasma concentration.
Measured: From pre-dose up to Day 8
Area Under the Plasma Concentration-Time Curve (AUC)
Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf)
Measured: From pre-dose up to Day 8
Terminal Elimination Half-Life (t1/2)
Evaluation of the elimination half-life of BW-50218
Measured: From pre-dose up to Day 8
Urine Pharmacokinetic Parameters (Renal Clearance, CLr)
Renal clearance calculated as CLr = CAe/Plasma AUC 0-24. Ae=cumulative amount excreted in urine (mg). AUC 0-24 = Area under the plasma concentration - time curve from 0 to 24 hours(e.g.mg*h/mL)
Measured: From pre-dose up to 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202630 Apr 2028

First posted11 May 2026
Study start18 May 2026
Primary completion30 Jun 2027 (estimated)
Study completion30 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Participants StudyStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07577479
Sponsor's protocol ID: BW-50218-1002
Status last verified: Jun 2026
First submitted: 13 Apr 2026
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingObservational study
Screening Protocol
Pain
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment

All Healthy Participants Study trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
ClinicalTrials.gov ID: NCT07577479
Acronym / sponsor ID: BW-50218-1002
Conditions: Healthy Participants Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 24 participants (actual)
Lead sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 May 2026 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Apr 2028 (estimated)
First posted: 11 May 2026 (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.

A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants

Detailed description

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
BW-50218 Dose1	Experimental	Drug: BW-50218 InjectionSingle dose of BW-50218 injection (Dose 1)
BW-50218 Dose 2	Experimental	Drug: BW-50218 InjectionSingle dose of BW-50218 injection (Dose 2)
BW-50218 Dose 3	Experimental	Drug: BW-50218 InjectionSingle dose of BW-50218 injection (Dose 3)
Saline Placebo	Placebo comparator	Drug: Saline (0.9% NaCl)Single dose of Saline Placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Capable of providing written informed consent and complying with all study procedures for the duration of the study.
Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
Male participants with partners of childbearing potential must agree to use effective contraception.

Key exclusion criteria (5 listed)

Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
Recent hospitalization or a significant acute medical event.
History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
Positive test for hepatitis B, hepatitis C, or HIV.

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
BW-50218 InjectionSolution for injection	Drug	BW-50218 Dose 2, BW-50218 Dose 3, BW-50218 Dose1
Saline (0.9% NaCl)Solution for injection	Drug	Saline Placebo

Primary outcome

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
Time frame: From baseline up to Day 360 (End of Study)
Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events. The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).
Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be fagged.
Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
Time frame: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.
Time frame: From baseline up to Day 360 (End of Study)
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
Time frame: From baseline up to Day 360 (End of Study)
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
Change from Baseline in Physical Examination Findings
Time frame: From baseline up to Day 360 (End of Study)
Assessment of clinically significant changes in physical examination findings
Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Time frame: From baseline up to Day 360 (End of Study)
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

5 secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: From pre-dose up to Day 8
Time to Maximum Plasma Concentration (Tmax)
Time frame: From pre-dose up to Day 8
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: From pre-dose up to Day 8
Terminal Elimination Half-Life (t1/2)
Time frame: From pre-dose up to Day 8
Urine Pharmacokinetic Parameters (Renal Clearance, CLr)
Time frame: From pre-dose up to 24 hours post-dose

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 23 Sep 2026.
Individual participant dataSharing planned: No. A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.

Related trials for Healthy Participants Study

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingObservational study
Screening Protocol
Pain
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment

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.

Yuqiong Li study director

Shanghai Argo Biopharmaceutical Co., Ltd.

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 BW-50218 Injection and Saline (0.9% NaCl) in people with Healthy Participants Study, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 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 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. 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?

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?

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?

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES) (time frame: From baseline up to Day 360 (End of Study)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07577479.

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 Sep 2026.