Actively Recruiting
A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
Led by eleva GmbH · Updated on 2026-04-21
39
Participants Needed
16
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old and no more than 50 years old (healthy volunteers).
- Participants must be overtly healthy based on medical evaluation (healthy volunteers).
- Body weight between 50 kg (male)/45 kg (female) and 110 kg with BMI 18-32 kg/m2 (inclusive).
- Participants with childbearing potential must use highly effective contraception during the study and for 90 days after last dose.
- Participants must have a negative pregnancy test at screening (childbearing potential).
- Provide written informed consent.
- Patients must have a confirmed diagnosis of C3 glomerulopathy by kidney biopsy (C3G patients).
- Patients must have proteinuria at screening (C3G patients).
- Patients must have stable or worsening kidney disease on stable optimized treatment for at least 30 days prior to screening (C3G patients).
You will not qualify if you...
- History of significant diseases affecting endocrine, cardiovascular, liver, kidney, immune, neurological, or other major systems.
- Any medical or psychiatric condition compromising ability to participate.
- Recent febrile illness or active infection within 14 days prior to screening.
- History of severe allergies or anaphylactic reactions.
- Known hypersensitivity to any study drug components.
- Elevated liver enzymes above specified limits.
- Current or chronic liver disease, except Gilbert's syndrome or asymptomatic gallstones.
- Received complement modifying treatment within 6 months prior to dosing.
- Participation in another clinical study within 3 months or 5 half-lives prior to dosing.
- Prolonged QTc interval or risk factors for heart rhythm disorders.
- Employees or relatives of the sponsor or investigator.
- Inability to comply with protocol or unstable social situation.
- Blood donation within 90 days prior to baseline or plans to donate during study.
- Excessive alcohol consumption above specified weekly limits.
- High daily intake of caffeine or xanthine-containing products above specified amounts.
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Medizinische Universität Wien
Vienna, Austria
Actively Recruiting
2
Cliniques universitaires Saint-Luc
Brussels, Belgium
Actively Recruiting
3
Fakultni Thomayerova nemocnice
Prague, Czechia
Actively Recruiting
4
Hôpital Européen Georges-Pompidou HEGP
Paris, France
Not Yet Recruiting
5
Centre Hospitalier Universitaire De Toulouse
Toulouse, France
Actively Recruiting
6
Laiko General Hospital Of Athens
Athens, Greece
Actively Recruiting
7
Pauls Stradins Clinical University Hospital
Riga, Latvia
Actively Recruiting
8
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
9
Amsterdam UMC Stichting
Amsterdam, Netherlands
Actively Recruiting
10
Hospital Curry Cabral - Centro Hospitalar de Lisboa Central - ULS Sao José
Lisbon, Portugal
Actively Recruiting
11
Fundacio Puigvert
Barcelona, Spain
Not Yet Recruiting
12
Hospital Universitario 12 De Octubre
Madrid, Spain
Actively Recruiting
13
Clinica Universidad De Navarra
Pamplona, Spain
Actively Recruiting
14
Hospital Universitario Virgen De La Macarena
Seville, Spain
Actively Recruiting
15
University Hospital Virgen Del Rocio S.L.
Seville, Spain
Actively Recruiting
16
Karolinska University Hospital
Huddinge, Sweden
Actively Recruiting
Research Team
J
Julia Flugel
CONTACT
D
Daniela Wittmann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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