RecruitingPhase 1NCT06714006

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

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

Sponsor

PYC Therapeutics

Enrollment

166 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PYC-003 for people with autosomal dominant polycystic kidney disease (adpkd. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPYC-003

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

Locations(10)

South Coast Renal, Brockway House, Level 1, Suite 8, 82-86 Queen Street,

Southport, Gold Coast, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital, Clinic G-Reception 133, Level 1, Clinical Building, Burnside Drive

Liverpool, New South Wales, Australia

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Westmead Hospital, Clinical Research Unit, Level 6, B Wing/Building, Hawkesbury Road

Westmead, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Sunshine Hospital, Western Centre for Health Research and Education, Level 3, 176-190 Furlong Road

Saint Albans, Victoria, Australia

Linear Clinical Research

Joondalup, Western Australia, Australia

Pacific Clinical Research Network Auckland

Takapuna, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06714006

Related Trials

Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)

NCT0716103743 locations

RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A PROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY

NCT075353851 location

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

NCT074541741 location

Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease

NCT072600711 location