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SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06144710
Study type Interventional
Source Hangzhou Sumgen Biotech Co., Ltd.
Contact Jing Zhang, Docter
Phone 86-13816357098
Email Zhangj_fudan@163.com
Status Recruiting
Phase Phase 1
Start date November 10, 2023
Completion date October 24, 2025
View Details
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