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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PYC-003, a Peptide-phosphorodiamidate Morpholino Oligonucleotide Conjugate, in Healthy Adult Participants and Adult Participants with Confirmed PKD1 Mutation-associated Autosomal Dominant Polycystic Kidney Disease

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Trial Profile

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PYC-003, a Peptide-phosphorodiamidate Morpholino Oligonucleotide Conjugate, in Healthy Adult Participants and Adult Participants with Confirmed PKD1 Mutation-associated Autosomal Dominant Polycystic Kidney Disease

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Mar 2025

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At a glance

  • Drugs PYC 003 (Primary)
  • Indications Polycystic kidney disease; Telomeric 22q13 Monosomy Syndrome
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors PYC Therapeutics

    • Most Recent Events

    • 18 Mar 2025 Planned number of patients changed from 60 to 56.
    • 26 Feb 2025 Protocol was amended to changed the time frame of primary endpoint from 2.5 years to 24 weeks.
    • 26 Feb 2025 Planned End Date changed from 1 Jan 2027 to 1 Jan 2026.

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