Healthy VolunteersPhase 1NCT06212804
A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants
A Phase 1 study testing VIS954 in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VIS954
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to 19 Jul 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participant between 18 to 55 years of age, inclusive, at the screening visit.
- Non-Japanese participant: Participant does not meet the criteria specified below for 'Japanese Participant'.
- Japanese participant: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant's 4 grandparents were born in Japan and recognized to be 'Japanese').
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit.
- Total body weight between 50.0 and 120.0 kg, inclusive, at the screening visit.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
Show all 10Show fewer
- Willing and able to participate in the study for the defined duration of the study.
- Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 1 year or surgically sterile for at least 3 months, or will agree to use highly effective methods of contraception from the period prior to study enrollment until 30 days after Day 56; women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at baseline prior to administration of the study intervention.
- Male participants with female partners of childbearing potential must agree to use double barrier contraception or abstain from sex during the study and until 90 days after Day 56. Male participants must agree to refrain from sperm donation for the duration of the study and until 90 days after Day 56. This criterion may be waived for male participants who have had a vasectomy greater than 6 months prior to enrollment.
- Healthy, as determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations), as judged by the principal investigator.
Who cannot join
- Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
- Participant is participating in another clinical study of any investigational drug, device, or intervention or has received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, before baseline (Day -1).
- Previous receipt of antibody or biologic therapy.
- History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 SC injection formulation.
- Blood pressure > 160/100 mmHg or < 90/50 mmHg (may be repeated once if abnormal), at the screening visit or Day -1.
- History of any infection requiring hospitalization or treatment with antivirals, antibiotics, or systemic antifungals within 3 months prior to screening.
Show all 21Show fewer
- Received a vaccination, other than COVID-19 vaccination, during the 30 days prior to administration of the first dose of study intervention. A COVID-19 vaccination cannot be received within 7 days prior to the first dose of study intervention and until 14 days after the last dose.
- Has received any prescription or nonprescription (over-the-counter) medication during the last 30 days or 5 half-lives, whichever is longer, preceding baseline (Day -1), with the exception of acetaminophen, ibuprofen, naproxen (or other over-the-counter nonsteroidal anti-inflammatory drugs [NSAID]), hormonal contraceptives, topical medications, vitamins, and dietary or herbal remedies.
- Any participant who has a recent history of alcohol or drug/chemical abuse, at the discretion of the investigator, will be excluded.
- Enrolled participants must abstain from consumption of nicotine containing products from Day -1 through discharge.
- Enrolled participants must abstain from consumption of cannabinoids from Day-1 through end of study.
- For the duration of the study, enrolled male participants should not consume more than 15 standard drinks per week (7 days) and female participants should not consume more than 10 standard drinks per week (7 days). A standard drink equals 10 g of alcohol. Enrolled participants must abstain from consuming alcohol 48 hours prior to check-in on Day -1 through discharge.
- Participant with a positive urine drug or alcohol breath screen test result at screening or Day -1. The urine drug screen and alcohol breath screen may be repeated once at the discretion of the investigator. The urine drug screen also screens for methylenedioxymethamphetamine and propoxyphene. If a participant tests positive on these tests, inclusion of that participant into the study will be based on the principal investigator's judgment with consultation, as needed, with the medical monitor and the sponsor.
- Any chronic infectious disease (eg, chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary or systemic tuberculosis [TB], chronic viral hepatitis such as hepatitis C or hepatitis B, or human immunodeficiency virus [HIV] infection).
- Participant who has donated > 500 mL of blood within 60 days prior to start of the screening visit or the participant has donated any plasma within 7 days prior to baseline (Day -1).
- Coronavirus disease 2019:
- Current symptoms of infection.
- Diagnosis of COVID-19 (reverse transcription polymerase chain reaction [RT-PCR], antigen testing, or clinical diagnosis) in the 21 days prior to screening.
- Ongoing diagnosis of "Long-COVID" symptoms, due to a prior COVID-19 infection.
- Is an employee of the clinical research team (any sponsor or research site employee), or has a family member who is an employee of these organizations.
- Participant is judged by the investigator or the medical monitor to be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-controlled, Double Blind, Single Ascending Dose, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Male and Female Participants
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
Read the detailed description
The study will be conducted in 6 sequential cohorts. Each cohort will enroll 9 participants, randomized to VIS954 or placebo at a ratio of 7:2.
On Day 1, a single dose of VIS954 or placebo will be administered SC. Sentinel participants will be utilized in each cohort. After 14 days, the safety data will be evaluated and a decision to admit and dose the next cohort will be made.
The total duration of the clinical study per participant will be up to 102 days (approximately 4 months).
- Conditions
- Healthy Volunteers
- Being tested
- VIS954, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS954Biological
A humanized IgG4 monoclonal antibody.
PlaceboOther
VIS954 Placebo
| Study group | Role | What they receive |
|---|---|---|
| VIS954 Dose 1 | Experimental | A single VIS954 Dose 1 will be administered subcutaneously on Day 1 Receives: Biological: VIS954 |
| VIS954 Dose 2 | Experimental | A single VIS954 Dose 2 will be administered subcutaneously on Day 1 Receives: Biological: VIS954 |
| VIS954 Dose 3 | Experimental | A single VIS954 Dose 3 will be administered subcutaneously on Day 1 Receives: Biological: VIS954 |
| VIS954 Dose 4 | Experimental | A single VIS954 Dose 4 will be administered subcutaneously on Day 1 Receives: Biological: VIS954 |
| VIS954 Dose 5 | Experimental | A single VIS954 Dose 5 will be administered subcutaneously on Day 1 Receives: Biological: VIS954 |
| VIS954 Dose 6 | Experimental | A single VIS954 Dose 6 will be administered subcutaneously on Day 1 Receives: Biological: VIS954 |
| Placebo | Placebo comparator | A single Placebo dose will be administered subcutaneously on Day 1 for 2 participants in each cohort. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product or was an important medical event that jeopardized the participant or required medical or surgical intervention to prevent 1 of the other outcomes listed above. TEAEs were AEs that first occurred or worsened in severity after the study intervention administration, and up to Day 71 (including the follow-up period) after the study intervention administration.
Measured: From study intervention administration (Day 1) up to end of follow-up (Day 71)
Wong-Baker FACES Pain Rating Scale
The Wong-Baker FACES Pain Rating Scale was a subjective self-report that was used to record each participant's perception of pain associated with their injection. The scale ranged from 0 to 10 and showed a series of faces ranging from a happy face at 0 which represented "no hurt" to a crying face at 10 which represented "hurts worst." Based on the faces and descriptions, the participant recorded their level of pain. Higher scores indicated more severe pain.
Measured: Day 1 (1 and 4 hours post-dose), Day 2 (24 hours post-dose), and on Days 3 and 29
Secondary outcomes (8)
Maximum Serum Concentration (Cmax) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The pharmacokinetic (PK) parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Time of Maximum Serum Concentration (Tmax) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Area Under the Concentration-Time Curve From Pre-dose Extrapolated to Infinite Time (AUC0-inf) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Area Under the Concentration-Time Curve From Pre-dose to the Last Quantifiable Concentration (AUC0-last) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Apparent Terminal Elimination Half-Life (t1/2) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Apparent Volume of Distribution (Vd/F) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Apparent Clearance After Extravascular Dosing (CL/F) of VIS954
Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.
Measured: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Time Spent Above 40 Percentage Receptor Occupancy (RO) for Neutrophils
Blood samples were collected at the specified time points to characterize the effect of VIS954 binding. The time spent above 40% RO was defined as duration in hours from date and time of dosing until the date and time of pharmacodynamic (PD) collection when %RO >40%. Baseline was defined as the last non-missing measurement taken prior to reference start date (including unscheduled assessments).
Measured: Baseline (Day -1) up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start21 Nov 2023
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1, randomized, placebo-controlled, double-blind, single ascending dose study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212804
- Sponsor's protocol ID
- VIS954-101
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Double Blind, Single Ascending Dose, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT06212804
- Acronym / sponsor ID
- VIS954-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
Detailed description
The study will be conducted in 6 sequential cohorts. Each cohort will enroll 9 participants, randomized to VIS954 or placebo at a ratio of 7:2.
On Day 1, a single dose of VIS954 or placebo will be administered SC. Sentinel participants will be utilized in each cohort. After 14 days, the safety data will be evaluated and a decision to admit and dose the next cohort will be made.
The total duration of the clinical study per participant will be up to 102 days (approximately 4 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Phase 1, randomized, placebo-controlled, double-blind, single ascending dose study
| Arm | Type | Receives |
|---|---|---|
| VIS954 Dose 1 | Experimental | Biological: VIS954A single VIS954 Dose 1 will be administered subcutaneously on Day 1 |
| VIS954 Dose 2 | Experimental | Biological: VIS954A single VIS954 Dose 2 will be administered subcutaneously on Day 1 |
| VIS954 Dose 3 | Experimental | Biological: VIS954A single VIS954 Dose 3 will be administered subcutaneously on Day 1 |
| VIS954 Dose 4 | Experimental | Biological: VIS954A single VIS954 Dose 4 will be administered subcutaneously on Day 1 |
| VIS954 Dose 5 | Experimental | Biological: VIS954A single VIS954 Dose 5 will be administered subcutaneously on Day 1 |
| VIS954 Dose 6 | Experimental | Biological: VIS954A single VIS954 Dose 6 will be administered subcutaneously on Day 1 |
| Placebo | Placebo comparator | Other: PlaceboA single Placebo dose will be administered subcutaneously on Day 1 for 2 participants in each cohort. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female participant between 18 to 55 years of age, inclusive, at the screening visit.
- Non-Japanese participant: Participant does not meet the criteria specified below for 'Japanese Participant'.
- Japanese participant: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant's 4 grandparents were born in Japan and recognized to be 'Japanese').
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit.
- Total body weight between 50.0 and 120.0 kg, inclusive, at the screening visit.
Key exclusion criteria (21 listed)
- Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
- Participant is participating in another clinical study of any investigational drug, device, or intervention or has received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, before baseline (Day -1).
- Previous receipt of antibody or biologic therapy.
- History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 SC injection formulation.
- Blood pressure > 160/100 mmHg or < 90/50 mmHg (may be repeated once if abnormal), at the screening visit or Day -1.
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 |
|---|---|---|
| VIS954A humanized IgG4 monoclonal antibody. | Biological | VIS954 Dose 1, VIS954 Dose 2, VIS954 Dose 3, VIS954 Dose 4, VIS954 Dose 5, VIS954 Dose 6 |
| PlaceboVIS954 Placebo | Other | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From study intervention administration (Day 1) up to end of follow-up (Day 71)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product or was an important medical event that jeopardized the participant or required medical or surgical intervention to prevent 1 of the other outcomes listed above. TEAEs were AEs that first occurred or worsened in severity after the study intervention administration, and up to Day 71 (including the follow-up period) after the study intervention administration.
Wong-Baker FACES Pain Rating Scale
Time frame: Day 1 (1 and 4 hours post-dose), Day 2 (24 hours post-dose), and on Days 3 and 29
The Wong-Baker FACES Pain Rating Scale was a subjective self-report that was used to record each participant's perception of pain associated with their injection. The scale ranged from 0 to 10 and showed a series of faces ranging from a happy face at 0 which represented "no hurt" to a crying face at 10 which represented "hurts worst." Based on the faces and descriptions, the participant recorded their level of pain. Higher scores indicated more severe pain.
8 secondary outcomes
Maximum Serum Concentration (Cmax) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Time of Maximum Serum Concentration (Tmax) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Area Under the Concentration-Time Curve From Pre-dose Extrapolated to Infinite Time (AUC0-inf) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Area Under the Concentration-Time Curve From Pre-dose to the Last Quantifiable Concentration (AUC0-last) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Apparent Terminal Elimination Half-Life (t1/2) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Apparent Volume of Distribution (Vd/F) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Apparent Clearance After Extravascular Dosing (CL/F) of VIS954
Time frame: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71
Time Spent Above 40 Percentage Receptor Occupancy (RO) for Neutrophils
Time frame: Baseline (Day -1) up to Day 71
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
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Screening Protocol
Pain
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 VIS954 in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. 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 10 inclusion and 21 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 24 Apr 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 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?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: From study intervention administration (Day 1) up to end of follow-up (Day 71)). The study lists 2 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 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.