A Randomized, Double-blind, Placebo-controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Characteristics of SG301 SC Injection in Single-dose Healthy Subjects and Multiple-dose Systemic Lupus Erythematosus (SLE) Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus (SLE).
∙ Part A (healthy volunteers)
• Male healthy adults aged 18-50 years (inclusive);
• Male participants weighed 50-100 kg (inclusive) with the body mass index of 19.0-27.0 kg/m2 (inclusive);
• Participants whose partners are of childbearing potential must agree to use effective contraceptive methods throughout the study period and for 6 months following the last dose.
∙ Part B (SLE participants)
• Males or females aged 18-65 years (inclusive);
• BMI 18.5-30.0 kg/m2 (inclusive);
• Have diagnosed as SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria, with inadequate response or intolerance to or having relapsed despite the standard treatment;
• SELENA-SLEDAI score \>4 and ≤12;
• Serologically ANA and/or anti-ds-DNA antibody tested positive;
• Having received a standard treatment for at least 12 weeks prior to the first dose that has remained at a stable dose for at least 4 weeks prior to the first dose;
• Laboratory values at screening meets the following criteria:
‣ Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2ULN, total bilirubin \<1.5×ULN;
⁃ Renal function: creatinine (Cr) and urea ≤1.5×ULN; eGFR \>60 ml/min (calculated by the MDRD formula); urine total protein-creatinine ratio ≤3.0 g/g or 24h urine protein ≤3.5 g;
⁃ Bone marrow function: Hb≥100g/L, WBC≥3.0×109/L, PLT≥75×109/L;
⁃ Participants who are of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive methods throughout the study period and for 6 months following the last dose.