Phase 1 Study of CPV-104 to Evaluate Safety and Body Processing in Healthy Adults and Patients With C3 Glomerulopathy

What this Trial Is About

Researchers are evaluating CPV-104, a new medicine designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy C3G, a very rare kidney disorder. This phase 1 trial is the first time CPV-104 is being tested in people, including both healthy adults and adults with C3G, to assess its safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study has two parts Part 1 involves healthy volunteers receiving a single intravenous dose of CPV-104 or a placebo in a randomized, double-blind manner across several dose levels. Part 2 includes patients with C3G receiving four weekly intravenous doses of CPV-104 without placebo. Doses are escalated if the medicine is tolerated, and a Safety Review Committee regularly reviews results to ensure safety before progressing. Participants will undergo close monitoring throughout the study, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For C3G patients, kidney function will also be observed. The primary outcome is the incidence of severe and serious adverse drug reactions up to Day 29 for healthy volunteers and Day 50 for C3G patients. The total study duration varies by part, with detailed safety assessments conducted throughout.

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