Lead Sponsor

Corbus Pharmaceuticals Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•1. ≥ 18 years of age at the time Informed Consent is signed.
•2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
•3. Disease duration ≤ 6 years from the first non-Raynaud's symptom.
•4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.

•1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
•2. Any of the following values for laboratory tests at Screening:
•1. A positive pregnancy test in women of childbearing potential;
•2. Hemoglobin \< 9 g/dL for males and \< 8 g/dL for females;
•3. Neutrophils \< 1.0 ×10\^9/L;
•4. Platelets \< 75 ×10\^9/L;
•5. Creatinine clearance \< 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;
•6. Aspartate aminotransferase or alanine aminotransferase \> 2.0 × upper limit of normal.
•3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.