HealthyPhase 1NCT06937593
A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954
A Phase 1 study testing VIS954 in people with Healthy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult 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
- 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 3 Feb 2026
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participant between 18 and 55 years of age, inclusive, at the screening visit.
- 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 in this protocol.
- Willing and able to participate in the trial for the defined duration of the trial.
- 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 trial enrollment until 90 days after Week 20 (or the last dose); women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening.
- Male participants must agree to use double barrier contraception or abstain from sex during the trial and until 90 days after Week 20 (or the last dose). Male participants must agree to refrain from sperm donation for the duration of the trial and until 150 days after the last dose. This criterion may be waived for male participants who have had a vasectomy greater than 6 months prior to enrollment.
- Healthy, as determined by pretrial medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests), 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 treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
- Participant is participating in another clinical trial 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.
- Receipt of blood products within 6 months prior to screening.
- History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 subcutaneous (SC) injection formulation.
- Previous exposure to VIS954.
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- Blood pressure > 140/90 mmHg or < 90/60 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.
- Received a vaccination, other than Coronavirus Disease 2019 (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.
- For the duration of the trial, 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 each administration of study intervention.
- Enrolled participants must abstain from consumption of nicotine containing products from Day-1 through discharge from the trial site clinic (Day 3).
- Enrolled participants must abstain from consumption of cannabinoids from Day-1 through end of trial.
- Participant with a positive urine drug and alcohol screen test result at screening or baseline. The urine drug and alcohol screen may be repeated once at the discretion of the investigator. The urine drug screen includes screening for cannabinoids, methylenedioxymethamphetamine, and propoxyphene. If a participant tests positive on these tests, inclusion of that participant into the trial 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 (COVID-19):
- 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 trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Participants
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.
Read the detailed description
The study will be conducted in 3 sequential cohorts. Each cohort will enroll 8 participants, randomized to VIS954 or placebo at a ratio of 6:2.
In each cohort, participants will be administered 6 doses of VIS954 or placebo with a dosing frequency of once every 2 weeks (Q2W). A Safety Monitoring Committee (SMC) will review the data and approve escalation to the next planned dose level.
The total duration of the clinical trial for each participant will be up to approximately 7 months, including the screening period.
- Conditions
- Healthy
- Being tested
- VIS954, Placebo
- Keywords
- Monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS954Drug
A humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
PlaceboDrug
VIS954 Placebo
| Study group | Role | What they receive |
|---|---|---|
| VIS954 - Low Dose | Experimental | VIS954 Low Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 Receives: Drug: VIS954 |
| VIS954 - Medium Dose | Experimental | VIS954 Medium Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 Receives: Drug: VIS954 |
| VIS954 - High Dose | Experimental | VIS954 High Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 Receives: Drug: VIS954 |
| Placebo | Placebo comparator | Placebo will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Number and Percentage of Adverse Events (AEs) that first occurred or worsened in severity after the study intervention administration.
Measured: 169 days
Maximum serum concentration after administration of VIS954 over time
Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess maximum serum concentration over time
Measured: 169 days
Area under the concentration-time curve from time zero extrapolated to time t
Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess area under the concentration-time curve from time zero extrapolated to time t (AUC 0-t)
Measured: 169 days
Secondary outcomes (1)
VIS954 Percentage Receptor Occupancy
Pharmacodynamic parameter to characterize and evaluate VIS954 binding to target receptor
Measured: 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start13 Mar 2025
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J Winkle, MD, Principal investigator, Anaheim Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937593
- Sponsor's protocol ID
- VIS954-102
- Status last verified
- Jun 2026
- First submitted
- 9 Apr 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06937593
- Acronym / sponsor ID
- VIS954-102
- Conditions
- Healthy
- Keywords
- Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 22 Apr 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 purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.
Detailed description
The study will be conducted in 3 sequential cohorts. Each cohort will enroll 8 participants, randomized to VIS954 or placebo at a ratio of 6:2.
In each cohort, participants will be administered 6 doses of VIS954 or placebo with a dosing frequency of once every 2 weeks (Q2W). A Safety Monitoring Committee (SMC) will review the data and approve escalation to the next planned dose level.
The total duration of the clinical trial for each participant will be up to approximately 7 months, including the screening period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VIS954 - Low Dose | Experimental | Drug: VIS954VIS954 Low Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
| VIS954 - Medium Dose | Experimental | Drug: VIS954VIS954 Medium Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
| VIS954 - High Dose | Experimental | Drug: VIS954VIS954 High Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female participant between 18 and 55 years of age, inclusive, at the screening visit.
- 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 in this protocol.
- Willing and able to participate in the trial for the defined duration of the trial.
Key exclusion criteria (23 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 treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
- Participant is participating in another clinical trial 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.
- Receipt of blood products within 6 months prior to screening.
- History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 subcutaneous (SC) injection formulation.
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 immunoglobulin G4 (IgG4) monoclonal antibody (mAb) | Drug | VIS954 - High Dose, VIS954 - Low Dose, VIS954 - Medium Dose |
| PlaceboVIS954 Placebo | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 169 days
Number and Percentage of Adverse Events (AEs) that first occurred or worsened in severity after the study intervention administration.
Maximum serum concentration after administration of VIS954 over time
Time frame: 169 days
Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess maximum serum concentration over time
Area under the concentration-time curve from time zero extrapolated to time t
Time frame: 169 days
Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess area under the concentration-time curve from time zero extrapolated to time t (AUC 0-t)
1 secondary outcome
VIS954 Percentage Receptor Occupancy
Time frame: 169 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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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.
Peter J Winkle, MD principal investigator
Anaheim Clinical Trials
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, 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 8 inclusion and 23 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 3 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: 169 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.