NCT07323173

Brief Summary

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients with systemic lupus erythematosus.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 29, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

December 16, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

November 29, 2025

Last Update Submit

April 9, 2026

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)

    Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-047 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) During treatment.

    From first dose until last visit(within 85 days after drug injection)

Secondary Outcomes (4)

  • Cmax

    From first dose until last visit(within 85 days after drug injection)

  • Tmax

    From first dose until last visit(within 85 days after drug injection)

  • Immunogenicity

    From first dose until last visit(within 85 days after drug injection)

  • Assessment of Pharmacodynamics

    From first dose until last visit(within 85 days after drug injection)

Study Arms (2)

LBL-047 for Injection

EXPERIMENTAL

LBL-047 for Injection,Single subcutaneous injection.

Drug: LBL-047 for Injection

LBL-047 placebo for injection

ACTIVE COMPARATOR

LBL-047 placebo for injection,Single subcutaneous injection.

Drug: LBL-047 placebo for injection

Interventions

LBL-047 for InjectionDRUG

Single subcutaneous injection

Also known as: LBL-047
LBL-047 for Injection
LBL-047 placebo for injectionDRUG

Single subcutaneous injection

Also known as: LBL-047 placebo
LBL-047 placebo for injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily sign and date the informed consent form (ICF) and be willing and able to comply with the scheduled visits, treatment plan, laboratory test, and other study procedures.
  • Age ≥ 18 and ≤ 60 years at the time of signing the ICF.
  • Part A:Determined by the investigator to be in good health at the time of signing the ICF.
  • Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening.
  • Females of childbearing potential are willing to use highly effective contraception during the study and for 6 months after administration of the study drug and to avoid egg donation.Women of non-childbearing potential include: those with documented surgical sterilization or documented menopause.
  • Male of childbearing potential are willing to use highly effective contraception during the study and for 6 months after study drug administration and to avoid sperm donation.Men without fertility potential include those with: A semen sample investigation that confirms azoospermia, definitive evidence of infertility, or a history of vasoligation.For the purpose of this study, men with a "low sperm count" (or "subfertility") are not considered infertile.

You may not qualify if:

  • Part A:Symptoms or history of any significant disease, including but not limited to cardiovascular, hepatic, renal or any other disease that may interfere with the study results.
  • Part A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram (ECG), chest X-ray, and abdominal ultrasound.
  • Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
  • Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis).
  • Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study.
  • At screening, women of childbearing potential were positive for pregnancy.follicle stimulating hormone (FSH) did not reach postmenopausal level in postmenopausal women (defined as amenorrhoea ≥ 12 months before screening).
  • Large tattoo, scar or other condition that may interfere with assessment at the injection site.
  • unable to tolerate venipuncture, difficulty in blood collection or has a history of needle/blood phobic disorder.
  • The investigator determines that there are other conditions unsuitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

Xiangya School of Medicine of Central South University

Changsha, Hunan, 410028, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337099, China

NOT YET RECRUITING

Shanghai JiaoTong University School of Medicine，Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

NOT YET RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xian Jiaotong University

Xian, Shanxi, 710004, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621051, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Injections

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • xianmin meng

    Shanghai Public Health Clinical Center

    PRINCIPAL INVESTIGATOR

  • shuang ye

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

  • sheng chen

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lei liu

CONTACT

025-83378099liulei@leadsbiolabs.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2025

First Posted

January 7, 2026

Study Start

December 16, 2025

Primary Completion (Estimated)

December 16, 2027

Study Completion (Estimated)

December 16, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)