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A Phase 1 clinical trial in humans involving healthy participants and patients with C3 glomerulopathy to evaluate the safety, tolerability, and pharmacokinetics of CPV-104.
THE PURPOSE OF THIS STUDY IS TO DETERMINE WHETHER CPV-104 (THE DRUG BEING STUDIED) IS SAFE FOR USE IN PEOPLE (SAFETY), THE MANAGEABILITY OF SIDE EFFECTS (TOLERABILITY), THE BLOOD CONCENTRATIONS OF CPV-104 AND FACTOR H (AN IMPORTANT PROTEIN IN THE HUMAN BODY INVOLVED IN THE IMMUNE SYSTEM) IN THE BLOOD (PHARMACOKINETICS), AND WHETHER CPV-104 TRIGGERS A DEFENSIVE REACTION IN THE BODY AGAINST FOREIGN SUBSTANCES (IMMUNOGENICITY).
Technical Summary
- FIRST PHASE 1 CLINICAL TRIAL IN HUMANS INVOLVING HEALTHY PARTICIPANTS AND PATIENTS WITH C3 GLOMERULOPATHY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF CPV-104.
- Code EudraCT: 2024-517992-19
- Protocol number: CPV-104-101
- Promoter: eleva GmBH
- Molecule/Drug: CPV-104
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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