SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus (NCT06144710) | Clinical Trial Compass
CompletedPhase 1
SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus
China48 participantsStarted 2023-11-10
Plain-language summary
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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events(Part A and Part B)
Timeframe: From baseline through the end of study. Part A: Average 2 months per subject, Part B: Average 5 months per subject.
. Serologically ANA and/or anti-ds-DNA antibody tested positive;
Exclusion criteria
. Have a history of allergies or likely to be allergic to the investigational drug or any of their ingredients judged by the investigators;
. Have previously received drugs of the same target (CD38);
. Have participated in a clinical trial of any drug or medical device within 3 months or 5 half-lives prior to dosing, whichever is longer;
. Have received any prescription drugs or Chinese herbal medicines within 4 weeks prior to dosing, or any non-prescription or dietary supplements within 2 weeks prior to dosing;
. Have infections within 2 weeks prior to first dose (including but not limited to viral, bacterial, or fungal infections);
. Have experienced symptomatic herpes zoster within 3 months prior to dosing;
. Presence of any of the following diseases assessed by the investigator as abnormal with clinical significance within 6 months prior to dosing;
. Have a history of cardiovascular diseases within 6 months prior to dosing: chronic congestive heart failure (New York Heart Association \[NYHA\] 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.), and familial long QT interval syndrome, etc.;