Study of CM313 in Subject With IgA Nephropathy

Sponsor
Keymed Biosciences Co.Ltd
Study ID
NCT06830395
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CM313 — BIOLOGICAL
    CM313(SC) injection
  • Placebo — DRUG
    Matched placebo

Study Details

This study is divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2027
Completion
Aug 31, 2028

Study Design

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

Arms

  • Experimental: Part A: CM313 low dose
  • Experimental: Part A: CM313 high dose
  • Experimental: Part B: CM313 low dose with low frequency
  • Experimental: Part B: CM313 low dose with high frequency
  • Placebo Comparator: Part B: Placebo matching the volume of low dose CM313
  • Experimental: Part B: CM313 high dose with low frequency
  • Experimental: Part B: CM313 high dose with high frequency
  • Placebo Comparator: Part B: Placebo matching the volume of high dose CM313

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to 108 weeks ]

Central Contacts

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