IASO-782 in Systemic Lupus Erythematosus

ConditionSLE - Systemic Lupus Erythematosus

Trial statusNot yet recruiting

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 volunteers

Qualifiers

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
Drug
Each 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
Drug
Each 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 groups

Group A: Experimental groupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai IASO Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: