A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: C3 Glomerulopathy (C3G), Healthy Adult Participants
In brief
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.
Key facts
- Study ID
- NCT07483827
- Run by
- eleva GmbH
- People needed
- 39
- Starts
- 2025-06-26
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Karolinska University Hospital — Huddinge, Sweden (enrolling)
- Cliniques universitaires Saint-Luc — Brussels, Belgium (enrolling)
- Fakultni Thomayerova nemocnice — Prague, Czechia (enrolling)
- Hôpital Européen Georges-Pompidou HEGP — Paris, France (enrolling)
- Centre Hospitalier Universitaire De Toulouse — Toulouse, France (enrolling)
- Laiko General Hospital Of Athens — Athens, Greece (enrolling)
- Pauls Stradins Clinical University Hospital — Riga, Latvia (enrolling)
- Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
- Amsterdam UMC Stichting — Amsterdam, Netherlands (enrolling)
- Hospital Curry Cabral - Centro Hospitalar de Lisboa Central - ULS Sao José — Lisbon, Portugal (enrolling)
- University Hospital Virgen Del Rocio S.L. — Seville, Spain (enrolling)
- Medizinische Universität Wien — Vienna, Austria (enrolling)
- Hospital Universitario 12 De Octubre — Madrid, Spain (enrolling)
- Clinica Universidad De Navarra — Pamplona, Spain (enrolling)
- Hospital Universitario Virgen De La Macarena — Seville, Spain (enrolling)
- University Clinical Center of Serbia — Belgrade, Serbia
- Fundacio Puigvert — Barcelona, Spain
Full record on ClinicalTrials.gov
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