Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Corbus Pharmaceuticals Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
