ZB-106-SS-201, Tibulizumab, for SSc

Inclusion Criteria:
*  Male or female, 18 to 75 years of age
*  Body mass index between 18.0 and 38.0 kg/m²
*  Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
*  Has diffuse cutaneous SSc, defined as mRSS \>0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
*  Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years
*  mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive
*  FVC \>50% predicted
*  Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)

Exclusion Criteria:
*  Has any of the following complications:
*  Left ventricular failure
*  Pulmonary arterial hypertension
*  Renal crisis within previous 6 months
*  Gastrointestinal dysmotility within previous 3 months
*  Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
*  Current rheumatic disease other than SSc that could interfere with assessment of SSc
*  Lung disease requiring continuous oxygen therapy
*  Evidence or suspicion of active or latent tuberculosis
*  Active Crohn's Disease or ulcerative colitis