Actively Recruiting
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
Led by Nanjing Leads Biolabs Co.,Ltd · Updated on 2026-04-14
112
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nanjing Leads Biolabs Co.,Ltd
Lead Sponsor
S
Shanghai Public Health Clinical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LBL-047, a study drug given as a single subcutaneous injection, to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical effects in both healthy adults and patients with systemic lupus erythematosus (SLE). This Phase I, double-blind, randomized, placebo-controlled trial aims to understand how the drug behaves in the body and its initial effects in people with mild to moderate SLE. The study is divided into two parts. Part A involves healthy adults receiving escalating doses of LBL-047 or placebo through a single subcutaneous injection, with dose increases guided by a Safety Monitoring Committee. Part B enrolls adult patients with mild to moderate SLE, confirmed safe doses from Part A are administered as a single injection. Participants are randomized to either the drug or placebo groups. Participants will be monitored from the first dose until 85 days after injection for treatment-emergent and serious adverse events, drug levels in the body, immune responses, and pharmacodynamic effects. Assessments include laboratory tests and clinical evaluations to track safety and biological activity. The study plans to enroll 76 participants, with possible additions, and involves scheduled visits, laboratory testing, and safety monitoring throughout the observation period.
CONDITIONS
Brief Title
A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign and date the informed consent form and agree to comply with study visits, treatment, laboratory tests, and procedures.
- Age between 18 and 60 years at the time of consent.
- For healthy adults (Part A): Determined by investigator to be in good health.
- For patients with systemic lupus erythematosus (Part B): Mild to moderate SLE with SLEDAI-2K score between 4 and 10 at screening.
- Females of childbearing potential willing to use highly effective contraception during the study and for 6 months after study drug administration; women of non-childbearing potential include those with surgical sterilization or menopause.
- Males of childbearing potential willing to use highly effective contraception during the study and for 6 months after study drug administration; men without fertility potential include those with confirmed azoospermia, infertility evidence, or vasoligation history.
You will not qualify if you...
- For healthy adults (Part A): History or symptoms of significant disease including cardiovascular, liver, kidney, or other illnesses that could affect study results.
- For healthy adults (Part A): Clinically significant abnormalities in vital signs, physical exam, lab tests, ECG, chest X-ray, or abdominal ultrasound.
- For patients with SLE (Part B): History of organ or stem cell/bone marrow transplant.
- For patients with SLE (Part B): Currently receiving treatment for chronic infections such as pneumocystosis, cytomegalovirus, herpes viruses, or atypical mycobacteriosis.
- Major surgery within 90 days before dosing or planned during the study.
- Women of childbearing potential who test positive for pregnancy or postmenopausal women without confirmed menopause.
- Large tattoos, scars, or conditions interfering with injection site assessment.
- Inability to tolerate blood draws or history of needle phobia.
- Any other conditions deemed unsuitable by the investigator for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 85 days after injection
Participants receive a single subcutaneous injection of either LBL-047 or placebo and are monitored for safety, tolerability, and preliminary efficacy.
Multiple visits during the 85-day period for assessments
Trial Site Locations
Total: 11 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Not Yet Recruiting
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Not Yet Recruiting
3
Xiangya School of Medicine of Central South University
Changsha, Hunan, China, 410028
Not Yet Recruiting
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
5
Pingxiang People's Hospital
Pingxiang, Jiangxi, China, 337099
Not Yet Recruiting
6
Shanghai JiaoTong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, China, 200001
Not Yet Recruiting
7
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 200083
Actively Recruiting
8
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
9
The Second Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China, 710004
Not Yet Recruiting
10
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
11
Mianyang Central Hospital
Mianyang, Sichuan, China, 621051
Not Yet Recruiting
Research Team
L
lei liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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