drugset
drugset / Trial / NCT06144710

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

NCT06144710 ↗

Phase 1 Active not recruiting 48 enrolled Hangzhou Sumgen Biotech Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2023-11-10
Primary completion
2026-01-07
Completion
2026-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject SG301 Monoclonal antibody 1 mg/kg Subcutaneous
Subject SG301 Monoclonal antibody 2 mg/kg Subcutaneous
Subject SG301 Monoclonal antibody 4 mg/kg Subcutaneous
Subject SG301 Monoclonal antibody 8 mg/kg Subcutaneous
Subject SG301 Monoclonal antibody 12 mg/kg Subcutaneous

Indications

systemic lupus erythematosus