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

NCT07483827 | Recruiting Phase 1 DMC

• 2 other identifiers: CPV-104-1012024-517992-19-00
• Study Type: interventional
• Target: 39
• Locations: 11 countries
• Sites: 16

Brief 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.

Conditions

C3 Glomerulopathy (C3G); Healthy Adult Participants

Keywords

CPV-104; C3G; Complement System; kidney disease; kidney; Factor H

Outcome Measures

Primary Outcomes (1)

• Incidence of severe drug reactions (severe ADRs) and serious adverse drug reactions (SADRs)

  Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G

Secondary Outcomes (31)

• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse drug reactions (ADRs)

  Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G

• Change from baseline in patient reported parameters (patients with C3G only)

  Up to Day 50

• Change from baseline in physician global assessment (patients with C3G only)

  Up to Day 50

• Change from baseline in safety laboratory parameters, physical examinations, vital signs, and 12-lead ECG parameters

  Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G

• Cmax of CPV-104 after single dose (SAD-HV)

  Up to Day 29

Other Outcomes (2)

• Change from baseline in estimated glomerular filtration rate (eGFR)

  Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G

• Change from baseline in urine protein-to-creatinine ratio (UPCR)

  Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G

Study Arms (2)

Part 1 - SAD-HV: Single ascending dose cohorts in healthy subjects

EXPERIMENTAL

Healthy volunteer subject cohorts randomized 4:2 receiving a single dose of CPV-104 or placebo. The first cohort consisting of three volunteers will receive CPV-104 only. Dose escalation will occur if CPV-104 or placebo is tolerated.

Drug: CPV-104/Placebo

Part 2 - MAD-C3G: Multiple ascending dose cohorts in C3G patients

EXPERIMENTAL

Patients to receive multiple ascending doses of CPV-104, dosed weekly over 28 days. Dose escalation will occur if CPV-104 is tolerated.

Drug: CPV-104

Interventions

CPV-104/Placebo DRUG

CPV-104 or Placebo

Part 1 - SAD-HV: Single ascending dose cohorts in healthy subjects

CPV-104 DRUG

CPV-104

Part 2 - MAD-C3G: Multiple ascending dose cohorts in C3G patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 18 years old and no more than 50 years old, at the time of consent, and must be able to sign and date the informed consent form (ICF) themselves.

You may not qualify if:

• Body weight within 50 kg for male/ 45 kg for female to 110 kg and BMI within the range 18 - 32 kg/m2 (inclusive).
• Childbearing potential (CBP) participants should agree to use a highly effective method of contraception throughout the study and for 90 days after the last dose of the IMP.
• CBP participants should agree not to donate oocytes or freeze for future use for the purposes of assisted reproduction during the study and for a period of 90 days after the last dose of the IMP. Male participants should agree not to donate sperm or freeze sperm for future use for the purposes of assisted reproduction during the study and for a period of 90 days after the last dose of the IMP.
• CBP participants should have a negative pregnancy test at screening.
• Participant provides written informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Participant has a history of clinically significant disorders or diseases affecting the endocrine, gastrointestinal, cardiovascular, hematological, liver, immune, kidney, respiratory, reproductive, or neurological systems (such as stroke or epilepsy). Participants with a history of minor medical issues may be considered for the study at the investigator's discretion.
• Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
• Participant has a recent history of febrile illness or other evidence of a clinically significant active infection, within 14 days prior to screening.
• Participant has a history of severe allergies (e.g. to medications, food, or latex) or has experienced an anaphylactic reaction to food or medicine.
• Participant has a known hypersensitivity to any components of the IMP as stated in this protocol.
• Alanine transaminase (ALT) or Aspartate aminotransferase (AST) \>1.5 x upper limit of normal (ULN).
• Total Bilirubin \>1 x ULN, \> 1.5 x ULN if Gilbert's syndrome.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
• Participant has received any complement modifying treatment within 6 months prior to the first dosing day.
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Sponsors & Collaborators

• eleva GmbH: lead

Study Sites (17)

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

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

University Clinical Center of Serbia

Belgrade, Serbia

NOT YET RECRUITING

Fundacio Puigvert

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario 12 De Octubre

Madrid, Spain

RECRUITING

Clinica Universidad De Navarra

Pamplona, Spain

RECRUITING

Hospital Universitario Virgen De La Macarena

Seville, Spain

RECRUITING

University Hospital Virgen Del Rocio S.L.

Seville, Spain

RECRUITING

Karolinska University Hospital

Huddinge, Sweden

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bernd Jilma, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Flugel

CONTACT

+49 761 470 990; jflugel@elevabiologics.com

Daniela Wittmann

CONTACT

+49 761 470 990; dwittmann@elevabiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 - SAD-HV: Single ascending dose in healthy volunteers, Part 2 - MAD-C3G: Multiple ascending dose in C3G patients

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 19, 2026
• Study Start: June 26, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); SE (1); GR (1); FR (2); CZ (1); AU (1); LA (1); ES (5); LI (1); NL (1); PT (1)