MedTrace Logo

A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus

NCT07001839 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-06-03

No results posted yet for this study

Summary

The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with systemic lupus erythematosus (SLE). The main questions it aims to answer are:

* The safety, tolerability and maximum tolerated dose (MTD) of QLS4131 for Injection in participants with SLE.
* The recommended Phase 2 dose (RP2D) of QLS4131 for Injection in participants with SLE.

Participants will be administered different target dose of QLS4131 for Injection only once. A step-up dosing approach will be implemented at high dose level as determined by the safety monitoring committee.

Conditions

Interventions

DRUG

QLS4131 for Injection.

Eligible participants will be assigned to 1 of the 9 dose groups ranging from 0.06 μg/kg to 600 μg/kg.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-12-31
Completion
2026-12-31

More Related Trials

Entities

Diseases

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 NCT07001839 on ClinicalTrials.gov