Lead Sponsor

Genentech, Inc.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Weight of 45-150 kg at screening
•Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration from first non-Raynaud's symptom
•Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential for 4 months after last dose of study drug
•No clinically significant change in eligibility status
•Completion of the MAD and ability to roll over into the OSE within 5 days

•Active rheumatic autoimmune disease other than SSc requiring treatment with disease-modifying therapy
•Pulmonary disease with forced vital capacity (FVC) ≤ 50% of predicted
•History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
•History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
•Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug
•Major surgery within 8 weeks prior to screening, or major planned surgery during the study or within 3 months after the final dose
•Positive hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody test at screening
•Any serious medical condition or abnormality in clinical laboratory tests

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