NCT06144710

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	SG301 SC Injection	Subcutaneous injection every two weeks
DRUG	SG301 SC Placebo	Subcutaneous injection every two weeks

Timeline

• Start date: 2023-11-10
• Primary completion: 2026-01-07
• Completion: 2026-10-24
• First posted: 2023-11-22
• Last updated: 2026-03-09

Locations

10 sites across 1 country: China