Autoimmune DiseasesPhase 1NCT05418101
A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)
A Phase 1 study testing VIS171 in people with Autoimmune Diseases, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 10 sites in 5 countries.
Trial summary
This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- VIS171
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 28 Apr 2022to 13 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participant between 18 and 55 years of age, inclusive, at the screening visit (Part A and Part B [participants with selected autoimmune diseases]) or between 18 and 75 years of age, inclusive, at the screening visit (Part B [participants with specific autoimmune disease]).
- Body mass index between 17 and 35 kg/m^2.
- Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 2 years or surgically sterile for at least 3 months.
- 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 following the last dose of study intervention.
- Additional inclusion criterion for Part A:
- Healthy, as determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations).
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- Additional inclusion criteria for Part B (participants with specific autoimmune disease[s]):
- Diagnosis of a specified autoimmune disease based on standard criteria for the condition.
- Other criteria may apply depending on the autoimmune condition.
Who cannot join
- Prior and Concomitant Therapy
- Receipt of high dose corticosteroid therapy within 4 weeks prior to screening.
- Receipt of belimumab within 6 months prior to screening.
- History of treatment with rituximab or ocrelizumab (or other B cell-depleting agent) within 12 months prior to screening.
- History of cytotoxic medications within the preceding 12 months.
- Receipt of blood products within 6 months prior to screening.
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- Prior/Concurrent Clinical Study Experience:
- Receipt of any investigational product within 4 weeks or 5 half-lives of the respective product prior to signing of the ICF, whichever is greater.
- Currently participating in another clinical study of any investigational drug, device, or intervention.
- Diagnostic Assessments
- Participants with uncontrolled hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg in any position) or symptomatic hypotension.
- Any chronic infectious disease.
- Participant with a positive urine drug or alcohol breath screen test result at screening.
- Other Exclusions:
- Any participant who has a history of alcohol or drug/chemical abuse.
- Participant who has donated > 500 mL of blood within 60 days prior to the start of screening or any plasma within 7 days prior to baseline (Day -1).
- History of opportunistic infection requiring hospitalization or intravenous (IV) antimicrobial treatment within 1 year prior to randomization.
- History of major surgery within 12 weeks of screening or will require major surgery during the study.
- Clinically significant electrocardiographic abnormalities, at screening.
- A QT interval corrected for heart rate using Fridericia's correction (QTcF) > 450 msec for male participants or > 470 msec for female participants at screening.
- Participant has received an organ transplant.
- History of any significant cardiovascular disease or thrombotic episode.
- History of cancer, apart from: squamous or basal cell carcinoma of the skin that has been successfully treated; cervical cancer in situ that has been successfully treated.
- Coronavirus Disease 2019 (COVID-19): current symptoms of infection; diagnosis of COVID-19 in the 21 days prior to Screening; ongoing diagnosis of "Long-COVID" symptoms.
- 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.
- Additional exclusion criteria for Part A:
- Medical Conditions
- 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.
- Participant has a history or presence of proteinuria, chronic kidney disease, disease requiring immunosuppressive therapy (including systemic steroids), or is considered to be immunosuppressed for any other reason.
- History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
- Known immunodeficiency disorder.
- History of chronic infection or any infection requiring hospitalization or treatment with antivirals, antibiotics, or antifungal therapy within 30 days prior to administration of the study intervention.
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 × the upper limit of normal (ULN).
- Total bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if total bilirubin is fractionated and direct bilirubin < 35%).
- Known hepatic or biliary abnormalities.
- Additional exclusion criterion for Part A and Part B (participants with participants with specific autoimmune disease may apply depending upon the autoimmune condition).
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Bulgaria5 sites
UMHAT
Plovdiv, 4002
Ambulatory for Specialized Medical Help - skin and venereal diseases
Sofia, 1407
Comac Medical Ltd
Sofia, 1612
MBAL Sveta Sofia
Sofia, 1618
Diagnostic and Consultative Center Convex EOOD
Sofia, 1680
Germany2 sites
Universitaetsklinikum Bonn AöR
Bonn, 53127
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Rheinland-Pfalz, 55131
About this study
Official title: A Phase 1, First-in-human, 2-part Study (Part 1 is a Single Ascending Dose in Healthy Participants; Part 2 is a Multiple Ascending Dose Study in Participants With Autoimmune Disease) to Evaluate the Safety, PD and PK of VIS171
This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).
Read the detailed description
This is a multicenter, 2-part combined Single ascending dose (SAD) and Multiple ascending dose (MAD) First-in-Human (FIH) study to investigate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (Part A - SAD) and in participants with autoimmune inflammatory disease(s) (Part B - MAD).
Part A: Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Up to 5 cohorts are planned, each comprising 8 participants (6 VIS171 and 2 placebo).
Part B: Part B is an open-label, MAD basket assessment of SC VIS171 in participants with autoimmune inflammatory disease(s). Two to 3 cohorts are planned, each comprising 12 participants.
- Conditions
- Autoimmune Diseases
- Being tested
- VIS171, Placebo
- Keywords
- Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, Healthy participants
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS171Drug
Participants will receive VIS171 via SC route of administration.
PlaceboDrug
Participants will receive Placebo via SC route of administration
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1: Dose level 1 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). Receives: Drug: VIS171; Drug: Placebo |
| Part A Cohort 2: Dose level 2 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). Receives: Drug: VIS171; Drug: Placebo |
| Part A Cohort 3: Dose level 3 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). Receives: Drug: VIS171; Drug: Placebo |
| Part A Cohort 4: Dose level 4 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). Receives: Drug: VIS171; Drug: Placebo |
| Part A Cohort 5: Dose level 5 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). Receives: Drug: VIS171; Drug: Placebo |
| Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data | Experimental | Participants will be randomized to MAD dose of VIS171. Receives: Drug: VIS171 |
| Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data | Experimental | Participants will be randomized to MAD dose of VIS171. Receives: Drug: VIS171 |
| Part B Cohort 3: Dose level and regimen to be determined from prior MAD and SAD Cohort(s) | Experimental | Participants will be randomized to MAD dose of VIS171. Receives: Drug: VIS171 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
Measured: Part A: From screening up to Day 29; Part B: From screening up to Day 71
Secondary outcomes (8)
Part A and Part B: Mean change from baseline in absolute number (cells/μL) for Treg, helper T cells, cytotoxic T cells and natural killer cells
Measured: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Mean change from baseline in percentage for Treg, helper T cells, cytotoxic T cells and natural killer cells
Measured: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Maximum (peak) plasma VIS171 concentration (Cmax) over time
Measured: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Time of maximum (peak) plasma VIS171 concentration (tmax)
Measured: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A: Area under the concentration-time curve from time zero to the last observable concentration (AUClast) of VIS171
Measured: Part A: From baseline up to Day 29
Part A: Area under the concentration-time curve from time zero to infinity (AUC∞) for VIS171 concentration
Measured: Part A: From baseline up to Day 29
Part B: Area under the concentration-time curve over the dosing interval at steady-state (AUCtau)
Measured: Part B: From baseline up to Day 71
Part A and Part B: Number of participants with Anti-drug antibodies (ADA) positive for VIS171
Measured: Part A: Day 1, 15, and 29; Part B: Day 1, 15, 29, 43, and 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start28 Apr 2022
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Sequential
- Model description
- This phase 1 study has two parts. Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Part B is an open-label, MAD basket assessment of SC VIS171 in participants with an autoimmune inflammatory disease
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asher Schachter, MD, Principal investigator, Visterra, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418101
- Sponsor's protocol ID
- VIS171-101
- Other IDs
- 2021-006246-12
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, 2-part Study (Part 1 is a Single Ascending Dose in Healthy Participants; Part 2 is a Multiple Ascending Dose Study in Participants With Autoimmune Disease) to Evaluate the Safety, PD and PK of VIS171
- ClinicalTrials.gov ID
- NCT05418101
- Acronym / sponsor ID
- VIS171-101
- Conditions
- Autoimmune Diseases
- Keywords
- Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).
Detailed description
This is a multicenter, 2-part combined Single ascending dose (SAD) and Multiple ascending dose (MAD) First-in-Human (FIH) study to investigate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (Part A - SAD) and in participants with autoimmune inflammatory disease(s) (Part B - MAD).
Part A: Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Up to 5 cohorts are planned, each comprising 8 participants (6 VIS171 and 2 placebo).
Part B: Part B is an open-label, MAD basket assessment of SC VIS171 in participants with autoimmune inflammatory disease(s). Two to 3 cohorts are planned, each comprising 12 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This phase 1 study has two parts. Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Part B is an open-label, MAD basket assessment of SC VIS171 in participants with an autoimmune inflammatory disease
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1: Dose level 1 | Experimental | Drug: VIS171, Drug: PlaceboParticipants will be randomized to SAD dose of VIS171 (or placebo). |
| Part A Cohort 2: Dose level 2 | Experimental | Drug: VIS171, Drug: PlaceboParticipants will be randomized to SAD dose of VIS171 (or placebo). |
| Part A Cohort 3: Dose level 3 | Experimental | Drug: VIS171, Drug: PlaceboParticipants will be randomized to SAD dose of VIS171 (or placebo). |
| Part A Cohort 4: Dose level 4 | Experimental | Drug: VIS171, Drug: PlaceboParticipants will be randomized to SAD dose of VIS171 (or placebo). |
| Part A Cohort 5: Dose level 5 | Experimental | Drug: VIS171, Drug: PlaceboParticipants will be randomized to SAD dose of VIS171 (or placebo). |
| Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data | Experimental | Drug: VIS171Participants will be randomized to MAD dose of VIS171. |
| Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data | Experimental | Drug: VIS171Participants will be randomized to MAD dose of VIS171. |
| Part B Cohort 3: Dose level and regimen to be determined from prior MAD and SAD Cohort(s) | Experimental | Drug: VIS171Participants will be randomized to MAD dose of VIS171. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female participant between 18 and 55 years of age, inclusive, at the screening visit (Part A and Part B [participants with selected autoimmune diseases]) or between 18 and 75 years of age, inclusive, at the screening visit (Part B [participants with specific autoimmune disease]).
- Body mass index between 17 and 35 kg/m^2.
- Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 2 years or surgically sterile for at least 3 months.
- 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 following the last dose of study intervention.
- Healthy, as determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations).
Key exclusion criteria (36 listed)
- Prior and Concomitant Therapy
- Receipt of high dose corticosteroid therapy within 4 weeks prior to screening.
- Receipt of belimumab within 6 months prior to screening.
- History of treatment with rituximab or ocrelizumab (or other B cell-depleting agent) within 12 months prior to screening.
- History of cytotoxic medications within the preceding 12 months.
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 |
|---|---|---|
| VIS171Participants will receive VIS171 via SC route of administration. | Drug | Part A Cohort 1: Dose level 1, Part A Cohort 2: Dose level 2, Part A Cohort 3: Dose level 3, Part A Cohort 4: Dose level 4, Part A Cohort 5: Dose level 5, Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data, Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data, Part B Cohort 3: Dose level and regimen to be determined from prior MAD and SAD Cohort(s) |
| PlaceboParticipants will receive Placebo via SC route of administration | Drug | Part A Cohort 1: Dose level 1, Part A Cohort 2: Dose level 2, Part A Cohort 3: Dose level 3, Part A Cohort 4: Dose level 4, Part A Cohort 5: Dose level 5 |
Primary outcome
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
Time frame: Part A: From screening up to Day 29; Part B: From screening up to Day 71
8 secondary outcomes
Part A and Part B: Mean change from baseline in absolute number (cells/μL) for Treg, helper T cells, cytotoxic T cells and natural killer cells
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Mean change from baseline in percentage for Treg, helper T cells, cytotoxic T cells and natural killer cells
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Maximum (peak) plasma VIS171 concentration (Cmax) over time
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Time of maximum (peak) plasma VIS171 concentration (tmax)
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A: Area under the concentration-time curve from time zero to the last observable concentration (AUClast) of VIS171
Time frame: Part A: From baseline up to Day 29
Part A: Area under the concentration-time curve from time zero to infinity (AUC∞) for VIS171 concentration
Time frame: Part A: From baseline up to Day 29
Part B: Area under the concentration-time curve over the dosing interval at steady-state (AUCtau)
Time frame: Part B: From baseline up to Day 71
Part A and Part B: Number of participants with Anti-drug antibodies (ADA) positive for VIS171
Time frame: Part A: Day 1, 15, and 29; Part B: Day 1, 15, 29, 43, and 71
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 15 Apr 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher Schachter, MD principal investigator
Visterra, Inc.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIS171 in people with Autoimmune Diseases, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 10 sites in 5 countries.
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 36 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 15 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 10 sites in Bulgaria, Germany, Moldova, Netherlands, New Zealand. 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. 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?
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs) (time frame: Part A: From screening up to Day 29; Part B: From screening up to Day 71). 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 15 Apr 2026.