Condition: C3 Glomerulopathy (C3G) · Healthy Adult Participants · Sponsor: eleva GmbH
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.
This description comes directly from the study's public registry record.
Julia Flugel · +49 761 470 990 · jflugel@elevabiologics.com
Daniela Wittmann · +49 761 470 990 · dwittmann@elevabiologics.com
Always discuss trial participation with your own doctor first.
| Medizinische Universität Wien | Vienna, Austria | Recruiting |
| Cliniques universitaires Saint-Luc | Brussels, Belgium | Recruiting |
| Fakultni Thomayerova nemocnice | Prague, Czechia | Recruiting |
| Hôpital Européen Georges-Pompidou HEGP | Paris, France | Not Yet Recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse, France | Recruiting |
| Laiko General Hospital Of Athens | Athens, Greece | Recruiting |
| Pauls Stradins Clinical University Hospital | Riga, Latvia | Recruiting |
| Vilnius University Hospital Santaros Klinikos | Vilnius, Lithuania | Recruiting |
| Amsterdam UMC Stichting | Amsterdam, Netherlands | Recruiting |
| Hospital Curry Cabral - Centro Hospitalar de Lisboa Central - ULS Sao José | Lisbon, Portugal | Recruiting |
| Fundacio Puigvert | Barcelona, Spain | Not Yet Recruiting |
| Hospital Universitario 12 De Octubre | Madrid, Spain | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07483827