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RECRUITING
NCT07483827
PHASE1

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

Sponsor: eleva GmbH

View on ClinicalTrials.gov

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.

Official title: A Phase 1 First-in-Human Clinical Trial in Healthy Participants and Patients With C3-Glomerulopathy to Assess Safety, Tolerability, and Pharmacokinetics of CPV-104

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2025-06-26

Completion Date

2026-06

Last Updated

2026-03-19

Healthy Volunteers

Yes

Interventions

DRUG

CPV-104/Placebo

CPV-104 or Placebo

DRUG

CPV-104

CPV-104

Locations (16)

Medizinische Universität Wien

Vienna, Austria

Cliniques universitaires Saint-Luc

Brussels, Belgium

Fakultni Thomayerova nemocnice

Prague, Czechia

Hôpital Européen Georges-Pompidou HEGP

Paris, France

Centre Hospitalier Universitaire De Toulouse

Toulouse, France

Laiko General Hospital Of Athens

Athens, Greece

Pauls Stradins Clinical University Hospital

Riga, Latvia

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Amsterdam UMC Stichting

Amsterdam, Netherlands

Hospital Curry Cabral - Centro Hospitalar de Lisboa Central - ULS Sao José

Lisbon, Portugal

Fundacio Puigvert

Barcelona, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Clinica Universidad De Navarra

Pamplona, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

University Hospital Virgen Del Rocio S.L.

Seville, Spain

Karolinska University Hospital

Huddinge, Sweden