A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07751315
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ia:QLS2404 very low dose — DRUG
    a single subcutaneous dose of QLS2404 Injection in healthy participants
  • Ia:QLS2404 low dose — DRUG
    a single subcutaneous dose of QLS2404 Injection in healthy participants
  • Ia:QLS2404 middle dose — DRUG
    a single subcutaneous dose of QLS2404 Injection in healthy participants
  • Ia:QLS2404 high dose — DRUG
    a single subcutaneous dose of QLS2404 Injection in healthy participants
  • Ia:QLS2404 Max dose — DRUG
    a single subcutaneous dose of QLS2404 Injection in healthy participants
  • Ib:QLS2404 low dose — DRUG
    multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
  • Ib:QLS2404 middle dose — DRUG
    multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
  • Ib:QLS2404 high dose — DRUG
    multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)

Study Details

This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 11, 2026
Status verified
Jul 2026
Primary completion
Nov 7, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ia treatment group 1
  • Experimental: Ia treatment group 2
  • Experimental: Ia treatment group 3
  • Experimental: Ia treatment group 4
  • Experimental: Ia treatment group 5
  • Experimental: Ib treatment group 1
  • Experimental: Ib treatment group 2
  • Experimental: Ib treatment group 3

Primary Outcome Measure

Ia:the safety and tolerability of a single subcutaneous dose of QLS2404 Injection in healthy participants [ Time Frame: from the first single subcutaneous Inject of QLS2404 up to Day85 ]

Central Contacts

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