C3 Glomerulopathy (C3G)Phase 1Essential OneNCT07483827
A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
A Phase 1 study testing CPV-104 in people with C3 Glomerulopathy (C3G) and Healthy Adult Participants, run by eleva GmbH at 17 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- C3 Glomerulopathy (C3G), Healthy Adult Participants
- What is being tested?
- CPV-104
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 17 sitesin 12 countries
- Study dates
- 26 Jun 2025to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or results.
- 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.
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- Participant provides written informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Patient must be at least 18 years old, at the time of consent, and must be able to sign and date the informed consent form (ICF) themselves.
- Patient must have a diagnosis of C3G confirmed by historical renal biopsy.
- Patient must have proteinuria at screening.
- Patient must have stable or worsening renal disease, be on stable and optimized symptomatic treatment, in the opinion of the PI, for at least 30 days prior to screening (treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives, steroids).
- 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.
Who cannot join
- 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).
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- 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.
- Participation in any other clinical study with a medical device or investigational medicinal product concurrently or within 5 half-life times or 3 months before the first dosing day (whichever is longer).
- Presence of a QTc interval >450 ms for males or >460 ms for females, a history of risk factors for Torsades de Pointes (such as heart failure, cardiomyopathy, or a family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia, or concurrent use of medications known to prolong the QT/QTc interval.
- Participant is an employee of the sponsor or an employee or relative of the investigator.
- Participant is unable to comply with the protocol (e.g. clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, or otherwise unlikely to complete the study) or is, in the opinion of the investigator, otherwise unsuited for the study.
- Participant has made a blood donation or blood products within 90 days prior to Baseline or plans to donate blood during the study.
- Participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week. One unit is equivalent to 8 g of alcohol: a half pint (240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits).
- Study participant has a high consumption of caffeine- or other xanthine-containing products (≥300 mg of caffeine- or xanthine-equivalent per day) (1 cup of coffee ≈ 100 mg of caffeine; 1 cup of tea ≈ 30 mg of caffeine; 1 glass of cola ≈ 20 mg of caffeine).
- Patient has a history of clinically significant disorders or diseases affecting the endocrine, gastrointestinal, cardiovascular (including thromboembolic events like deep vein thrombosis, pulmonary embolism, known coagulopathy), 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.
- Patient 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.
- Patient had a recent history of febrile illness or other evidence of a clinically significant active infection, within 14 days prior to screening.
- Patient has a history of severe allergies (e.g. to medications, food, or latex) or has experienced an anaphylactic reaction to food or medicine.
- Patient has a known hypersensitivity to any components of the IMP as stated in this protocol.
- Patient had evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.
- Patient with other renal diseases that would interfere with interpretation of the study.
- Patient is receiving renal replacement therapy.
- Patient is receiving or planned for receiving plasmapheresis.
- Patient had a major organ transplant (e.g. heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
- Patient had a history or presence of any clinically relevant co-morbidities (e.g. advanced cardiac disease (NYHA class 4), severe pulmonary arterial hypertension (WHO class 4).
- Alanine transaminase (ALT) or Aspartate aminotransferase (AST) >2 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).
- Patient has received any complement modifying treatment within 6 months prior to the first dosing day.
- Patient in any other clinical study with a medical device or investigational medicinal product concurrently or within 5 half-life times or 3 months before study start (whichever is longer).
- Presence of a QTc interval >450 ms for males or >460 ms for females, a history of risk factors for Torsades de Pointes (such as heart failure, cardiomyopathy, or a family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia, or concurrent use of medications known to prolong the QT/QTc interval.
- Participant is an employee of the sponsor or an employee or relative of the investigator.
- Participant is unable to comply with the protocol (e.g. clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, or otherwise unlikely to complete the study) or is, in the opinion of the investigator, otherwise unsuited for the study.
- Participant has made a blood donation or blood products within 90 days prior to Baseline or plans to donate blood during the study.
- Participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week. One unit is equivalent to 8 g of alcohol: a half pint (~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits).
- Study participant has a high consumption of caffeine- or other xanthine-containing products (≥300 mg of caffeine- or xanthine-equivalent per day) (1 cup of coffee ≈ 100 mg of caffeine; 1 cup of tea ≈ 30 mg of caffeine; 1 glass of cola ≈ 20 mg of caffeine).
Trial locations and contacts
17 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 12 countries
Spain5 sites, 5 recruiting
- Recruiting
Fundacio Puigvert
Barcelona
- Recruiting
Hospital Universitario 12 De Octubre
Madrid
- Recruiting
Clinica Universidad De Navarra
Pamplona
- Recruiting
Hospital Universitario Virgen De La Macarena
Seville
- Recruiting
University Hospital Virgen Del Rocio S.L.
Seville
France2 sites, 2 recruiting
- Recruiting
Hôpital Européen Georges-Pompidou HEGP
Paris
- Recruiting
Centre Hospitalier Universitaire De Toulouse
Toulouse
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC Stichting
Amsterdam
Portugal1 site, 1 recruiting
- Recruiting
Hospital Curry Cabral - Centro Hospitalar de Lisboa Central - ULS Sao José
Lisbon
Serbia1 site, 1 recruiting
- Not yet recruiting
University Clinical Center of Serbia
Belgrade
About this study
Official title: A Phase 1 First-in-Human Clinical Trial in Healthy Participants and Patients With C3-Glomerulopathy to Assess Safety, Tolerability, and Pharmacokinetics of CPV-104
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).
Read more
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.
Read the detailed description
CPV-104-101 is a phase 1, first-in-human, dose-escalation, prospective trial, which will be conducted in two parts: Part 1 (Single Ascending Dose with healthy volunteers - SAD-HV) and Part 2 (Multiple Ascending Dose with C3G patients - MAD-C3G). Part 1 is double-blind, randomized, and placebo-controlled, while Part 2 is open-label and single-arm (CPV-104 only).
Following a screening period, 21 healthy volunteers who meet the eligibility criteria will be assigned to one of four cohorts in SAD-HV Part 1. Three healthy volunteers will be assigned to Cohort 1 within SAD-HV Part 1 to receive a single dose of CPV-104. After completion of Cohort 1, 18 healthy volunteers will be randomly allocated within SAD-HV Cohorts 2, 3, and 4 to receive a single dose of either CPV-104 or placebo.
After completion of SAD-HV Part 1, 18 C3G patients will be allocated within MAD-C3G Cohorts 5, 6, and 7 to receive four doses of CPV-104.
All treatments will be administered intravenously by a healthcare professional (HCP). Before dosing in Cohorts 2, 3, 4, 5, 6, and 7 can begin, safety data will be reviewed by an SRC. Safety data from Cohorts 2, 3 and 4 will be blinded for the principal investigators and the medical monitor in the SRC. Safety data will be unblinded for the three independent members of the SRC.
- Being tested
- CPV-104/Placebo, CPV-104
- Keywords
- CPV-104, C3G, Complement System, kidney disease, kidney, Factor H
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPV-104/PlaceboDrug
CPV-104 or Placebo
CPV-104Drug
CPV-104
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: CPV-104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe drug reactions (severe ADRs) and serious adverse drug reactions (SADRs)
Measured: 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)
Measured: 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)
Change in scores from baseline from the following patient reported outcome instruments:
- EuroQol 5 Dimension 5 Level (EQ 5D 5L)
- PROMIS® 29+2 Profile
- Kidney Disease Quality of Life - Short Form (KDQOL SF)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT Fatigue)
Measured: Up to Day 50
Change from baseline in physician global assessment (patients with C3G only)
Change from baseline in physician assessed global disease severity using a 0-100 scale (0 = no signs of disease, 100 = worst imaginable severity).
Measured: Up to Day 50
Change from baseline in safety laboratory parameters, physical examinations, vital signs, and 12-lead ECG parameters
Change from baseline in predefined safety assessments including:
- Clinical laboratory tests (chemistry, hematology, coagulation, urinalysis)
- Physical examination findings (abnormal findings)
- Vital signs (blood pressure, pulse, temperature, respiratory rate)
- ECG parameters (PR/PQ, QRS, QT/QTc, heart rate)
Measured: 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)
Maximum observed plasma concentration of CPV-104 after administration of a single IV dose.
Measured: Up to Day 29
Tmax of CPV-104 after single dose (SAD-HV)
Time to reach maximum observed plasma concentration of CPV-104 after a single IV dose.
Measured: Up to Day 29
AUC0-∞ of CPV-104 after single dose (SAD-HV)
Area under the plasma concentration-time curve from zero to infinity after a single IV dose of CPV-104.
Measured: Up to Day 29
Terminal half-life (t½) of CPV-104 after single dose (SAD-HV)
Terminal elimination half-life of CPV-104 after a single IV dose.
Measured: Up to Day 29
Clearance (CL) of CPV-104 after single dose (SAD-HV)
Total body clearance of CPV-104 from plasma after a single IV dose.
Measured: Up to Day 29
Volume of distribution (Vz) of CPV-104 after single dose (SAD-HV)
Volume of distribution of CPV-104 during the terminal phase after a single IV dose.
Measured: Up to Day 29
Cmax of CPV-104 after first dose (MAD-C3G)
Maximum observed plasma concentration of CPV-104 after the first weekly dose in the multiple-dose phase.
Measured: Up to Day 50
Tmax of CPV-104 after first dose (MAD-C3G)
Time to reach maximum observed plasma concentration of CPV-104 after the first weekly dose in the multiple-dose phase.
Measured: Up to Day 50
AUCτ of CPV-104 after first dose (MAD-C3G)
Area under the plasma concentration-time curve over the dosing interval after the first weekly dose of CPV-104.
Measured: Up to Day 50
Cmax of CPV-104 after fourth dose (MAD-C3G)
Maximum observed plasma concentration of CPV-104 after the fourth weekly dose in the multiple-dose phase.
Measured: Up to Day 50
Tmax of CPV-104 after fourth dose (MAD-C3G)
Time to reach maximum observed plasma concentration of CPV-104 after the fourth weekly dose in the multiple-dose phase.
Measured: Up to Day 50
AUCτ of CPV-104 after fourth dose (MAD-C3G)
Area under the plasma concentration-time curve over the dosing interval after the fourth weekly dose of CPV-104.
Measured: Up to Day 50
AUC0-∞ of CPV-104 after fourth dose (MAD-C3G)
Area under the plasma concentration-time curve extrapolated to infinity after the fourth weekly dose of CPV-104.
Measured: Up to Day 50
Terminal half-life (t½) of CPV-104 after fourth dose (MAD-C3G)
Terminal elimination half-life of CPV-104 after the fourth weekly dose.
Measured: Up to Day 50
Clearance (CL) of CPV-104 after fourth dose (MAD-C3G)
Total body clearance of CPV-104 from plasma after the fourth weekly dose.
Measured: Up to Day 50
Volume of distribution (Vz) of CPV-104 after fourth dose (MAD-C3G)
Volume of distribution of CPV-104 during the terminal phase after the fourth weekly dose.
Measured: Up to Day 50
Cmax of endogenous Factor H after single dose (SAD-HV)
Maximum observed plasma concentration of endogenous Factor H measured at the same pharmacokinetic timepoints as CPV-104 following a single IV dose.
Measured: Up to Day 29
Tmax of endogenous Factor H after single dose (SAD)
Time to reach maximum observed plasma concentration of endogenous Factor H following a single IV dose.
Measured: Up to Day 29
AUC0-∞ of endogenous Factor H after single dose (SAD)
Area under the plasma concentration-time curve from zero to infinity for endogenous Factor H following a single IV dose.
Measured: Up to Day 29
Cmax of endogenous Factor H after first dose (MAD-C3G)
Maximum observed plasma concentration of endogenous Factor H measured at the same pharmacokinetic timepoints as CPV-104 after the first weekly dose in the multiple-dose phase.
Measured: Up to Day 8
Tmax of endogenous Factor H after first dose (MAD-C3G)
Time to reach maximum observed plasma concentration of endogenous Factor H after the first weekly dose in the multiple-dose phase.
Measured: Up to Day 8
AUCτ of endogenous Factor H after first dose (MAD-C3G)
Area under the plasma concentration-time curve over the dosing interval for endogenous Factor H after the first weekly dose.
Measured: Up to Day 8
Cmax of endogenous Factor H after fourth dose (MAD-C3G)
Maximum observed plasma concentration of endogenous Factor H after the fourth weekly dose in the multiple-dose phase.
Measured: Up to Day 50
Tmax of endogenous Factor H after fourth dose (MAD-C3G)
Time to reach maximum observed plasma concentration of endogenous Factor H after the fourth weekly dose.
Measured: Up to Day 50
AUCτ of endogenous Factor H after fourth dose (MAD-C3G)
Area under the plasma concentration-time curve over the dosing interval for endogenous Factor H after the fourth weekly dose.
Measured: Up to Day 50
AUC0-∞ of endogenous Factor H after fourth dose (MAD-C3G)
Area under the plasma concentration-time curve from zero to infinity for endogenous Factor H after the fourth weekly dose.
Measured: Up to Day 50
Incidence and titers of anti-drug antibodies (ADA)
Measured: Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start26 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 Glomerulopathy (C3G)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 - SAD-HV: Single ascending dose in healthy volunteers, Part 2 - MAD-C3G: Multiple ascending dose in C3G patients
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eleva GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernd Jilma, Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483827
- Sponsor's protocol ID
- CPV-104-101
- Other IDs
- 2024-517992-19-00
- Acronym
- Essential One
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Clinical Trial in Healthy Participants and Patients With C3-Glomerulopathy to Assess Safety, Tolerability, and Pharmacokinetics of CPV-104
- ClinicalTrials.gov ID
- NCT07483827
- Acronym / sponsor ID
- Essential One / CPV-104-101
- Keywords
- CPV-104, C3G, Complement System, kidney disease, kidney, Factor H
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- eleva GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CPV-104-101 is a phase 1, first-in-human, dose-escalation, prospective trial, which will be conducted in two parts: Part 1 (Single Ascending Dose with healthy volunteers - SAD-HV) and Part 2 (Multiple Ascending Dose with C3G patients - MAD-C3G). Part 1 is double-blind, randomized, and placebo-controlled, while Part 2 is open-label and single-arm (CPV-104 only).
Following a screening period, 21 healthy volunteers who meet the eligibility criteria will be assigned to one of four cohorts in SAD-HV Part 1. Three healthy volunteers will be assigned to Cohort 1 within SAD-HV Part 1 to receive a single dose of CPV-104. After completion of Cohort 1, 18 healthy volunteers will be randomly allocated within SAD-HV Cohorts 2, 3, and 4 to receive a single dose of either CPV-104 or placebo.
After completion of SAD-HV Part 1, 18 C3G patients will be allocated within MAD-C3G Cohorts 5, 6, and 7 to receive four doses of CPV-104.
All treatments will be administered intravenously by a healthcare professional (HCP). Before dosing in Cohorts 2, 3, 4, 5, 6, and 7 can begin, safety data will be reviewed by an SRC. Safety data from Cohorts 2, 3 and 4 will be blinded for the principal investigators and the medical monitor in the SRC. Safety data will be unblinded for the three independent members of the SRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part 1 - SAD-HV: Single ascending dose in healthy volunteers, Part 2 - MAD-C3G: Multiple ascending dose in C3G patients
| Arm | Type | Receives |
|---|---|---|
| Part 1 - SAD-HV: Single ascending dose cohorts in healthy subjects | Experimental | Drug: CPV-104/PlaceboHealthy 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. |
| Part 2 - MAD-C3G: Multiple ascending dose cohorts in C3G patients | Experimental | Drug: CPV-104Patients to receive multiple ascending doses of CPV-104, dosed weekly over 28 days. Dose escalation will occur if CPV-104 is tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or results.
- 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.
Key exclusion criteria (39 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPV-104/PlaceboCPV-104 or Placebo | Drug | Part 1 - SAD-HV: Single ascending dose cohorts in healthy subjects |
| CPV-104CPV-104 | Drug | Part 2 - MAD-C3G: Multiple ascending dose cohorts in C3G patients |
Primary outcome
Incidence of severe drug reactions (severe ADRs) and serious adverse drug reactions (SADRs)
Time frame: Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G
31 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse drug reactions (ADRs)
Time frame: 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)
Time frame: Up to Day 50
Change from baseline in physician global assessment (patients with C3G only)
Time frame: Up to Day 50
Change from baseline in safety laboratory parameters, physical examinations, vital signs, and 12-lead ECG parameters
Time frame: 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)
Time frame: Up to Day 29
Tmax of CPV-104 after single dose (SAD-HV)
Time frame: Up to Day 29
AUC0-∞ of CPV-104 after single dose (SAD-HV)
Time frame: Up to Day 29
Terminal half-life (t½) of CPV-104 after single dose (SAD-HV)
Time frame: Up to Day 29
Clearance (CL) of CPV-104 after single dose (SAD-HV)
Time frame: Up to Day 29
Volume of distribution (Vz) of CPV-104 after single dose (SAD-HV)
Time frame: Up to Day 29
Cmax of CPV-104 after first dose (MAD-C3G)
Time frame: Up to Day 50
Tmax of CPV-104 after first dose (MAD-C3G)
Time frame: Up to Day 50
AUCτ of CPV-104 after first dose (MAD-C3G)
Time frame: Up to Day 50
Cmax of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Tmax of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
AUCτ of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
AUC0-∞ of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Terminal half-life (t½) of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Clearance (CL) of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Volume of distribution (Vz) of CPV-104 after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Cmax of endogenous Factor H after single dose (SAD-HV)
Time frame: Up to Day 29
Tmax of endogenous Factor H after single dose (SAD)
Time frame: Up to Day 29
AUC0-∞ of endogenous Factor H after single dose (SAD)
Time frame: Up to Day 29
Cmax of endogenous Factor H after first dose (MAD-C3G)
Time frame: Up to Day 8
Tmax of endogenous Factor H after first dose (MAD-C3G)
Time frame: Up to Day 8
AUCτ of endogenous Factor H after first dose (MAD-C3G)
Time frame: Up to Day 8
Cmax of endogenous Factor H after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Tmax of endogenous Factor H after fourth dose (MAD-C3G)
Time frame: Up to Day 50
AUCτ of endogenous Factor H after fourth dose (MAD-C3G)
Time frame: Up to Day 50
AUC0-∞ of endogenous Factor H after fourth dose (MAD-C3G)
Time frame: Up to Day 50
Incidence and titers of anti-drug antibodies (ADA)
Time frame: Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernd Jilma, Prof. principal investigator
Medical University of Vienna
17 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPV-104 in people with C3 Glomerulopathy (C3G) and Healthy Adult Participants, run by eleva GmbH at 17 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, France, Austria, Belgium, Czechia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Flugel (+49 761 470 990, jflugel@elevabiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe drug reactions (severe ADRs) and serious adverse drug reactions (SADRs) (time frame: Up to Day 29 for Part 1 - SAD-HV and up to Day 50 for Part 2 - MAD-C3G). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.