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

NCT06714006 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-05-14

No results posted yet for this study

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 3 parts in this study, i.e. Part A, Part B and Part C

Conditions

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

DRUG

PYC-003

A peptide-phosphorodiamidate morpholino oligonucleotide conjugate administered as a single intravenous infusion

Sponsors & Collaborators

  • PYC Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714006 on ClinicalTrials.gov