Clinical Trial

Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003

Recruiting Phase 1
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Summary
This is a Phase 1, First-in-Human study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of PYC-003 in healthy adult participants and adult participants with confirmed PKD1 mutation-associated Autosomal Dominant Polycystic Kidney Disease (ADPKD) There are 4 parts in this study, i.e. Part A, Part B, Part C and Part D.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-06-09
notable Enrollment increased: 116 -> 166 participants 2026-06-09
minor Trial arms changed: 3 -> 4 2026-06-09
notable Primary completion pushed: 2026-09 -> 2028-11 2026-06-09
minor Completion pushed: 2027-03 -> 2028-11 2026-06-09
Trial Details
NCT Number NCT06714006
Lead Sponsor PYC Therapeutics
Conditions Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Enrollment 166 participants
Start Date 2025-04-07
Primary Completion 2028-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-27