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Tests treatment safety and results for C3 Glomerulopathy (C3G)
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
ClinicalTrials.gov ID: NCT07483827
What this study is testing
What is CPV-104?
CPV-104 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for c3 glomerulopathy (c3g).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Volunteers (Part 1 - SAD-HV) :
- 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...
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and...
You likely can't join if
- that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical...
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can join
- Healthy Volunteers (Part 1 - SAD-HV) :
- 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...
What rules you out
- 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...
- 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...
- 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. Exclusion Criteria Healthy Volunteers (Part 1 - SAD-HV) :
- Participant has a history of clinically significant disorders or diseases affecting the endocrine, gastrointestinal, cardiovascular, hematological, liver, immune, kidney, respiratory, reproductive, or neurological...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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. Exclusion Criteria C3G Patients (Part 2 - MAD-C3G) :
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Brussels, Belgium
- Prague, Czechia
- Paris, France
- Toulouse, France
- Athens, Greece
- Riga, Latvia
- Vilnius, Lithuania
- Amsterdam, Netherlands
- Lisbon, Portugal
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Seville, Spain
- Huddinge, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Brussels, Belgium; Prague, Czechia; Paris, France; Toulouse, France; Athens, Greece and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.