Actively Recruiting
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
Led by eleva GmbH · Updated on 2026-04-21
39
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes a new medicine called CPV-104. This medicine is designed to regulate the complement system, which can be overactive in a rare kidney condition called C3 glomerulopathy (C3G). The study includes both healthy adults and adults with C3G to understand how CPV-104 affects different groups and to check for any immune reactions or side effects. The trial has two parts. In the first part, healthy volunteers receive a single intravenous dose of CPV-104 or a placebo in a randomized, double-blind setting. In the second part, patients with C3G receive four weekly intravenous doses of CPV-104 without placebo. Dose escalation is allowed if the treatments are well tolerated. All doses are given by healthcare professionals, and a Safety Review Committee monitors safety data to decide on progressing with doses and groups. Participants will be closely monitored throughout the study with checks for side effects, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For patients with C3G, kidney function is also observed. The main focus is on safety rather than effectiveness. The study tracks serious and severe drug reactions up to Day 29 for healthy volunteers and Day 50 for C3G patients. Participation includes a screening period and follow-up assessments to ensure safety and gather important information about CPV-104.
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
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old and no more than 50 years old at consent.
- Must be overtly healthy for healthy volunteers or have a confirmed diagnosis of C3 glomerulopathy by kidney biopsy for patients.
- Body weight between 50 kg (male)/45 kg (female) and 110 kg with BMI between 18 and 32 kg/m2.
- Childbearing potential participants must agree to use effective contraception during the study and for 90 days after last dose.
- Negative pregnancy test required for childbearing potential participants at screening.
- Participants must provide written informed consent.
You will not qualify if you...
- History of significant disorders affecting endocrine, gastrointestinal, cardiovascular, hematological, liver, immune, kidney, respiratory, reproductive, or neurological systems.
- Any medical or psychiatric condition compromising 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 (ALT or AST) 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 with investigational product within 3 months or 5 half-lives.
- Abnormal heart rhythms or risk factors for serious arrhythmias.
- Blood donation within 90 days prior to baseline or planned during study.
- Excessive alcohol or high caffeine/xanthine consumption above defined limits.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 29 days
Healthy volunteers receive a single intravenous dose of CPV-104 or placebo in one of four dose-escalation cohorts. The first cohort receives CPV-104 only. Dose escalation occurs if treatment is tolerated.
1 dosing visit and additional visits for safety monitoring up to Day 29
Duration - Up to 50 days
Patients with C3-glomerulopathy receive multiple weekly intravenous doses of CPV-104 over 28 days in dose-escalation cohorts. Dose escalation occurs if treatment is tolerated.
Weekly dosing visits for 4 weeks and follow-up visits through Day 50
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
D
Daniela Wittmann
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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