Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

Sponsor
NovelMed Therapeutics
Study ID
NCT06454110
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NM8074 — DRUG
    NM8074 will be administered as an intravenous infusion. All subjects will be administered 17 mg/kg of NM8074 intravenously weekly for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Study Details

This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.

Key Dates

Start date
Feb 29, 2028
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Primary Outcome Measure

Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio [ Time Frame: Up to Study Day 99 ]

Central Contacts

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