A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

Official title

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

Overview

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.

Detailed description

This is a double-blind, randomized, placebo-controlled Phase I study to evaluate the safety, tolerability, PK, PD and immunogenicity of a single subcutaneous injection of LBL-047 in healthy adults and patients with systemic lupus erythematosus,the preliminary clinical efficacy of LBL-047 will also be evaluated in patients with systemic lupus erythematosus.

The study is divided into two parts.

Part A:Conduct studies in healthy adults.Part A is planned to be set up with 7 escalating dose groups.Participants were randomized to receive a single subcutaneous injection of LBL-047 or placebo.Dose escalation will be decided by the Safety Monitoring Committee (SMC).

Part B:Study in adult patients with systemic lupus erythematosus.Part B will be initiated at the dose levels that were confirmed to be safe and tolerable in Part A.Part B is planned to enroll patients with mild to moderate systemic lupus erythematosus and receive a single subcutaneous injection of LBL-047.

This study is expected to enroll 76 participants (with possible addition of 36 participants).

Interventions

• Drug LBL-047 for Injection
  Single subcutaneous injection
• Drug LBL-047 placebo for injection
  Single subcutaneous injection

Primary outcome measures

• Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE) [Time frame: From first dose until last visit(within 85 days after drug injection)]

Secondary outcome measures (4)

• Cmax [Time frame: From first dose until last visit(within 85 days after drug injection)]
• Tmax [Time frame: From first dose until last visit(within 85 days after drug injection)]
• Immunogenicity [Time frame: From first dose until last visit(within 85 days after drug injection)]
• Assessment of Pharmacodynamics [Time frame: From first dose until last visit(within 85 days after drug injection)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 11 centers

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
• Xiangya School of Medicine of Central South University — Changsha
• Nanjing Drum Tower Hospital — Nanjing
• Pingxiang People's Hospital — Pingxiang
• Shanghai JiaoTong University School of Medicine，Renji Hospital — Shanghai
• Shanghai Public Health Clinical Center — Shanghai
• Shanxi Bethune Hospital — Taiyuan
• … and 3 more centers

Identifiers

NCT: NCT07323173 · LBL-047-CN001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗