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.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
[Part A, B, C and D] Number of participants experiencing treatment emergent adverse events (AE) as assessed by CTCAE V5.0
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in vital signs (body temperature)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in vital signs (systolic and diastolic blood pressure)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in vital signs (pulse rate)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in vital signs (respiratory rate)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in 12-lead ECG (QT Interval)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in 12-lead ECG (QRS Duration)
Timeframe: Up to 98 weeks
Paula Cunningham Chief Preclinical Research Officer
[Part A, B, C and D] Changes from baseline in 12-lead ECG (QTcF Interval)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in 12-lead ECG (PR Interval)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in 12-lead ECG (Heart Rate)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in physical examination findings
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in hepatic clinical chemistry parameters (ALT, AST, ALP and GGT)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in standard renal clinical chemistry parameters (eGFR)
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in serum potassium, serum magnesium, and serum sodium
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in serum cystatin C
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in serum and urine creatinine
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in serum and urine osmolality
Timeframe: Up to 98 weeks
[Part A, B, C and D] Changes from baseline in urine magnesium and urine potassium
Timeframe: Up to 98 weeks