What is CPV-104 studying for C3 glomerulopathy?

CPV-104 is being studied to understand its safety, how it is processed in the body, and whether it causes immune reactions in people with C3 glomerulopathy and healthy volunteers. The trial aims to evaluate this new medicine's impact under the oversight of eleva GmbH to ensure participant safety during testing.

Who may be eligible for this C3 glomerulopathy clinical trial?

Adults aged 18 to 50 years who are either healthy or have a confirmed diagnosis of C3 glomerulopathy may be eligible. Participants must meet weight and health criteria and agree to use contraception if applicable. Please review eligibility criteria for more details.

Is there any cost to participate in this C3 glomerulopathy clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

Healthy Volunteers

ID07483827

Phase 1 Study of CPV-104 to Evaluate Safety and Body Processing in Healthy Adults and Patients With C3 Glomerulopathy

Led by eleva GmbH · Updated on 2026-07-31

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating CPV-104, a new medicine designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy C3G, a very rare kidney disorder. This phase 1 trial is the first time CPV-104 is being tested in people, including both healthy adults and adults with C3G, to assess its safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study has two parts Part 1 involves healthy volunteers receiving a single intravenous dose of CPV-104 or a placebo in a randomized, double-blind manner across several dose levels. Part 2 includes patients with C3G receiving four weekly intravenous doses of CPV-104 without placebo. Doses are escalated if the medicine is tolerated, and a Safety Review Committee regularly reviews results to ensure safety before progressing. Participants will undergo close monitoring throughout the study, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For C3G patients, kidney function will also be observed. The primary outcome is the incidence of severe and serious adverse drug reactions up to Day 29 for healthy volunteers and Day 50 for C3G patients. The total study duration varies by part, with detailed safety assessments conducted throughout.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Participants must be between 18 and 50 years old and able to provide informed consent.
Healthy volunteers must be overtly healthy based on medical evaluation including history, physical exam, labs, and cardiac monitoring.
Body weight between 50 kg (male)/45 kg (female) and 110 kg with BMI between 18 and 32 kg/m2.
Childbearing potential participants must use highly effective contraception during the study and for 90 days after last dose.
Childbearing potential participants must have a negative pregnancy test at screening.
Patients must have a confirmed diagnosis of C3 glomerulopathy by kidney biopsy.
Patients must have proteinuria and stable or worsening renal disease on stable treatment for at least 30 days prior to screening.
Patients must meet the same weight and contraception requirements as healthy volunteers.
Participants must provide written informed consent.

You will not qualify if you...

History of significant disorders affecting major organ systems or neurological conditions, except minor issues at investigator discretion.
Any medical or psychiatric condition that could affect participation.
Recent febrile illness or active infection within 14 days before screening.
History of severe allergies or anaphylactic reactions.
Known hypersensitivity to study drug components.
Elevated liver enzymes or bilirubin beyond specified limits.
Current or chronic liver disease except Gilbert's syndrome or asymptomatic gallstones.
Received complement modifying treatment within 6 months prior to dosing.
Exposure to multiple new chemical entities within 12 months (healthy volunteers).
Participation in other clinical studies within specified washout periods.
Prolonged QTc interval or risk factors for Torsades de Pointes.
Employment or relation to sponsor or investigator.
Inability to comply with study protocol.
Recent blood donation or plans to donate during study.
Excessive alcohol or caffeine consumption beyond specified limits.
Patients with monoclonal gammopathy, infections, malignancy, autoimmune diseases, or other secondary causes of C3G.
Patients receiving renal replacement therapy or plasmapheresis.
History of major organ or stem cell transplant.
Severe comorbidities such as advanced cardiac or pulmonary disease.

Research Team

Julia Flugel

Daniela Wittmann

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