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 — DRUGNM8074 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 1All 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
- Rekha Bansal, PhD2164402696
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