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

NCT06144710 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-09

No results posted yet for this study

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).

Conditions

  • Systemic Lupus Erythematosus (SLE)

Interventions

DRUG

SG301 SC Injection

Subcutaneous injection every two weeks

DRUG

SG301 SC Placebo

Subcutaneous injection every two weeks

Sponsors & Collaborators

  • Hangzhou Sumgen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144710 on ClinicalTrials.gov