LBL-047 for InjectionLBL-047 placebo for injection
LBL-047 for Injection: subcutaneous injection
LBL-047 placebo for injection: subcutaneous injection
Study summary
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
2. Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form.
3. Part A:Determined by the investigator to be in good health at the time of signing the ICF.
4. Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening.
5. 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.
6. 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.
Exclusion Criteria:
1. 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.
2. 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.
3. Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
4. Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis).
5. Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study.
6. 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).
7. Large tattoo, scar or other condition that may interfere with assessment at the injection site.
8. unable to tolerate venipuncture, difficulty in blood collection or has a history of needle/blood phobic disorder.
9. The investigator determines that there are other conditions unsuitable for participation in this study.
Primary outcome measure(s)
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE) — From first dose until last visit(within 89 days after drug injection) 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.
Trial sites (12)
Facility
City
Region
Status
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Anhui
Not Yet Recruiting
Beijing GoBroad Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
Xiangya School of Medicine of Central South University
Changsha
Hunan
Not Yet Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Not Yet Recruiting
Pingxiang People's Hospital
Pingxiang
Jiangxi
Recruiting
Shanghai JiaoTong University School of Medicine,Renji Hospital
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanghai Public Health Clinical Center
Shanghai
Shanghai Municipality
Recruiting
Shanxi Bethune Hospital
Taiyuan
Shanxi
Not Yet Recruiting
The Second Affiliated Hospital of Xian Jiaotong University
Xian
Shanxi
Recruiting
West China Hospital of Sichuan University
Chengdu
Sichuan
Recruiting
Mianyang Central Hospital
Mianyang
Sichuan
Recruiting
More Nanjing Leads Biolabs Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.