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A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy

NCT07483827 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-07-31

No results posted yet for this study

Summary

This study is the first time the new medicine CPV-104 is being tested in people. CPV-104 is designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy (C3G), an ultra-rare kidney disorder.

The study includes healthy adults and adult patients with C3G to assess safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study is divided in two part; in Part 1 (SAD), healthy volunteers receive one IV dose of CPV-104 or a placebo while in Part 2 (MAD) patients with C3G receive four weekly IV doses of CPV-104 (no placebo).

Participants will have close monitoring, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For those with C3G, researchers will also observe kidney function, although the main goal is safety, not testing effectiveness.

A Safety Review Committee will regularly review results to ensure it is safe to continue to the next dose or study group.

Conditions

  • C3 Glomerulopathy (C3G)
  • Healthy Adult Participants

Interventions

DRUG

CPV-104/Placebo

CPV-104 or Placebo

DRUG

CPV-104

CPV-104

Sponsors & Collaborators

  • eleva GmbH

    lead INDUSTRY

Principal Investigators

  • Bernd Jilma, Prof. · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Greece
  • Latvia
  • Lithuania
  • Netherlands
  • Portugal
  • Serbia
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07483827 on ClinicalTrials.gov