Actively Recruiting
A Phase I Study to Assess 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
104 weeks
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
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.
CONDITIONS
Official 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 follow study plans and procedures
- Age between 18 and 60 years at consent
- Part A: Good health confirmed by investigator
- Part B: Mild to moderate systemic lupus erythematosus with SLEDAI-2K score between 4 and 10 at screening
- Females of childbearing potential willing to use effective contraception during study and for 6 months after dosing and avoid egg donation; women of non-childbearing potential include those with surgical sterilization or menopause
- Males of childbearing potential willing to use effective contraception during study and for 6 months after dosing and avoid sperm donation; men without fertility potential confirmed by tests or history
You will not qualify if you...
- Part A: History or symptoms of significant disease including cardiovascular, liver, kidney, or other diseases affecting study results
- Part A: Clinical abnormalities in vital signs, physical exam, lab tests, ECG, chest X-ray, or abdominal ultrasound
- Part B: History of organ or bone marrow transplant
- Part B: Current treatment for chronic infections such as pneumocystosis, cytomegalovirus, herpes viruses, or atypical mycobacteriosis
- Major surgery within 90 days before dosing or planned during study
- Positive pregnancy test for women of childbearing potential at screening; postmenopausal women without confirmed FSH levels
- Large tattoo, scar, or other condition interfering with injection site assessment
- Unable to tolerate blood draws or history of needle/blood phobia
- Other conditions judged by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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