A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases

Sponsor
Sinocelltech Ltd.
Study ID
NCT06774664
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SCTC21C — BIOLOGICAL
    Drug: SCTC21C Administered SC

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases

Key Dates

Start date
Jan 31, 2025
Status verified
Jan 2025
Primary completion
Sep 30, 2027
Completion
Mar 31, 2029

Study Design

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

Arms

  • Experimental: Phase I: Dose-finding: Group 1
    Drug: SCTC21C Administered SC
  • Experimental: Phase I: Dose-finding: Group 2
    Drug: SCTC21C Administered SC
  • Experimental: Phase I: Dose-finding: Group 3
    Drug: SCTC21C Administered SC
  • Experimental: Phase I: Dose-finding: Group 4
    Drug: SCTC21C Administered SC
  • Experimental: Phase 2: Group 1
    Drug: SCTC21C Administered SC
  • Experimental: Phase 2: Group 2
    Drug: SCTC21C Administered SC
  • Placebo Comparator: Phase I: Dose-finding: Group 5
    Drug: SCTC21C Administered SC
  • Placebo Comparator: Phase I: Dose-finding: Group 6
    Drug: SCTC21C Administered SC
  • Placebo Comparator: Phase 1: Dose-finding: Group 7
    Drug: SCTC21C Administered SC
  • Placebo Comparator: Phase 2: Group 3
    Drug: SCTC21C Administered SC

Primary Outcome Measure

Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs). [ Time Frame: 36 Weeks ]

Central Contacts

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