A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)

Exclusion Criteria

• •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.
• •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.
• •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).