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A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form.

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBL-047 for Injection

    Drug

    subcutaneous injection

  • LBL-047 placebo for injection

    Drug

    subcutaneous injection

Treatment groups

117 Participants
are divided into 2 treatment groups
Group A: LBL-047 for InjectionExperimental treatment 1 intervention
Group B: LBL-047 placebo for injectionActive comparator 1 intervention

Trial outcomes

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.

Time frame
From first dose until last visit(within 89 days after drug injection)

Secondary outcomes

1

Cmax

Maximum drug concentration in plasma after administration.

Time frame
From first dose until last visit(within 89 days after drug injection)
2

Tmax

After administration,Time to reach maximum drug concentration in plasma.

Time frame
From first dose until last visit(within 89 days after drug injection)
3

Immunogenicity

The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.

Time frame
From first dose until last visit(within 89 days after drug injection)
4

Assessment of Pharmacodynamics

Drug therapy effect and adverse reaction, such as B cell level.

Time frame
From first dose until last visit(within 89 days after drug injection)

Other outcomes

Sponsors and contacts

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Nanjing Leads Biolabs Co.,Ltd

Lead sponsor

Shanghai Public Health Clinical Center

Collaborator

RenJi Hospital

Collaborator

Source ClinicalTrials.gov
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