Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
In brief
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.
Key facts
- Study ID
- NCT06714006
- Run by
- PYC Therapeutics
- People needed
- 166
- Starts
- 2025-04-07
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- South Coast Renal, Brockway House, Level 1, Suite 8, 82-86 Queen Street, — Southport, Gold Coast, Australia (enrolling)
- Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
- Liverpool Hospital, Clinic G-Reception 133, Level 1, Clinical Building, Burnside Drive — Liverpool, New South Wales, Australia (enrolling)
- Scientia Clinical Research — Randwick, New South Wales, Australia (enrolling)
- Sydney Adventist Hospital — Wahroonga, New South Wales, Australia (enrolling)
- Westmead Hospital, Clinical Research Unit, Level 6, B Wing/Building, Hawkesbury Road — Westmead, New South Wales, Australia (enrolling)
- Mater Hospital Brisbane — South Brisbane, Queensland, Australia (enrolling)
- St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
- Sunshine Hospital, Western Centre for Health Research and Education, Level 3, 176-190 Furlong Road — Saint Albans, Victoria, Australia (enrolling)
- Linear Clinical Research — Joondalup, Western Australia, Australia (enrolling)
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (enrolling)
- Pacific Clinical Research Network Auckland — Takapuna, Auckland, New Zealand (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.