drugset / Trial / NCT06714006

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

NCT06714006 ↗

Phase 1 Recruiting 166 enrolled PYC Therapeutics
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-04-07
Primary completion
2028-11
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject PYC-003 Oligonucleotide (other) — Intravenous