Status and phase
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About
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).
Full description
This is a phase I single ascending dose (SAD) study in healthy volunteers and multiple ascending dose (MAD) study in participants with mild or moderate SLE, which consists of Parts A and B. Part A adopts a single-center, open-label, dose escalation trial design, and Part B adopts a multi-center, randomized, double-blind, placebo-controlled trial design to evaluate the safety, tolerability, PK, and immunogenicity, preliminary efficacy of SG301 SC Injection in patients with mild to moderate SLE.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Part A (healthy volunteers)
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:
Exclusion criteria
Part A (healthy volunteers)
Part B (SLE participants)
Has a history of central nervous system disorders that require prohibited medicine treatment within 2 months prior to the first dose;
Presence of concomitant rheumatic diseases within 12 months prior to the first dose, including but not limited to rheumatoid arthritis, spondyloarthritis, dermatomyositis/polymyositis, Sjogren's syndrome, systemic sclerosis, mixed connective tissue disease, and overlap syndrome, etc.;
Presence of catastrophic antiphospholipid syndrome within 12 months prior to the first dose;
Has a history of non-SLE inflammatory skin or joint disease within 12 months prior to the first dose;
Presence of chronic active infection or acute infection within 4 weeks prior to first dose or superficial skin infection within 1 week prior to first dose;
A known or suspected history of immunosuppression;
Have undergone a major surgery within 12 weeks prior to the first dose or having an unhealed wound, ulcer or fracture, or planning to undergo a major surgery during the study;
Having participated in any clinical trial within 12 weeks prior to the first dose or have received other investigational products within 5 half-live, whichever is longer;
Have received any drugs targeting T or B lymphocytes (e.g., rituximab) within 6 months or cytokines or cytokines receptors (e.g., belimumab, telitacicept, etc.) treatment within 5 half-lives prior to the first dose;
Having received JAK inhibitors treatment within 12 weeks or 5 half-lives prior to the first dose, whichever is shorter;
Having received any of the following treatment within 12 weeks prior to the first dose:
Have diseases with major clinical significance within 6 months prior to first dose, including but not limited to circulatory system disorders, endocrine system disorders, nervous system disorders, blood system disorders, immune system disorders, and psychiatric disorders, etc.;
A history of cardiovascular diseases within 6 months prior to the first dose, including but not limited to chronic congestive heart failure (NYHA Class III or IV), myocardial infarction, severe heart diseases (e.g., unstable angina, cardiogenic shock, arrhythmias requiring treatment, heart valve diseases, hypertrophic cardiomyopathy, and rheumatic heart disease, etc.), QTcF >450 ms or familial long QT interval syndrome, poorly controlled hypertension;
Mycobacterium tuberculosis infection;
Presence of active hepatitis:
HIV antibody positive;
Both TPPA and RPR positive;
Known allergy to monoclonal antibody drugs or to any excipient of the investigational drug;
Having received a live or attenuated live vaccine within 4 weeks prior to the first dose or planning to do so during the study;
Have a history of major organ transplantation or hematopoietic stem cell/ bone marrow transplantation;
Have a history of malignancy within 5 years prior to first dose;
Participants with depression or suicidal tendency;
Have a history of heavy drinking or drug abuse within 3 months prior to first dose;
Pregnant or breastfeeding women, or women who plan to become pregnant or may breastfeed during the study and for 6 months following the last dose; male participants whose partner plans to become pregnant during the study.
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups, including a placebo group
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Central trial contact
Dafei Ding
Data sourced from clinicaltrials.gov
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