IASO-782 in Systemic Lupus Erythematosus
ConditionSLE - Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai IASO Biotechnology Co., Ltd
About this trial
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 75 years;
Clinically confirmed diagnosis of SLE before screening;
Currently receiving standard treatment regimens, including any single drug or combination of drugs;
Organ function or laboratory test is basically normal;
Disqualifiers
History of other primary malignant neoplasm within 5 years of screening;
A history of cardiac disease within the recent 3 months, including New York Heart Association (NYHA) Class III/IV congestive heart failure and cardiac arrhythmias requiring drug treatment;
Subjects with poorly controlled hypertension despite drug treatment;
A history of hypersensitivity to any component of the study drug or its excipients confirmed before screening;
Trial design
Design model
Parallel
Treatments tested in this trial
IASO-782 injection
DrugEach subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
Placebo
DrugEach subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events as assessed by CTCAE v6.0
The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Time frame
up to 25 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov