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

Sponsor
Nanjing Leads Biolabs Co.,Ltd
Study ID
NCT07323173
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • LBL-047 for Injection — DRUG
    subcutaneous injection
  • LBL-047 placebo for injection — DRUG
    subcutaneous injection

Study Details

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.

Key Dates

First listed
Jan 7, 2026
Start date
Dec 16, 2025
Status verified
Aug 2026
Primary completion
Dec 16, 2027
Completion
Dec 16, 2027

Study Design

Enrollment
117 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LBL-047 for Injection
    LBL-047 for Injection subcutaneous injection.
  • Active Comparator: LBL-047 placebo for injection
    LBL-047 placebo for injection subcutaneous injection.

Primary Outcome Measure

Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE) [ Time Frame: From first dose until last visit(within 89 days after drug injection) ]

Central Contacts

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