NCT05647811

Study of NM8074 in Adult C3 Glomerulopathy Patients

A Phase Ib, Open Label, Dose Escalation Study of NM8074 in Subjects With C3 Glomerulopathy (C3G)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: NovelMed Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.

Detailed description

The proposed study, NM8074-C3G-101, will enroll a planned number of 18 patients, with the potential to enroll more patients. There will be 3 cohorts with 6 patients each dosed at 5, 10, or 20 mg/kg depending on which cohort they are assigned to. Enrollment in the subsequent higher dose level cohort will occur after the previous cohort has been evaluated for safety.

Conditions

• C3 Glomerulopathy

Interventions

Type	Name	Description
DRUG	NM8074	NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.

Timeline

• Start date: 2027-05-01
• Primary completion: 2029-08-01
• Completion: 2030-07-01
• First posted: 2022-12-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study