Actively Recruiting
Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
Led by PYC Therapeutics · Updated on 2026-05-14
116
Participants Needed
10
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years (healthy volunteers) or 18 to 65 years (ADPKD participants)
- Healthy volunteers in good general health with no significant medical history
- BMI between 18.0 and 32.0 kg/m2 (healthy) or 18.0 and 35.0 kg/m2 (ADPKD) and weight at least 50 kg
- Non-smokers and no tobacco or nicotine use within 2 months prior to screening
- Normal or clinically acceptable laboratory values
- Estimated glomerular filtration rate (eGFR) at least 80 mL/min/1.73 m2 (healthy) or at least 30 mL/min/1.73 m2 (ADPKD)
- Women of childbearing potential must agree to use effective double barrier contraception
- Men must be surgically sterile or agree to use effective contraception if sexually active with women of childbearing potential
- Females must agree not to donate eggs from first IP administration until 30 days after study
- Males must agree not to donate sperm from first IP administration until 90 days after study
- Able and willing to attend study visits and comply with restrictions
- Able and willing to provide informed consent
You will not qualify if you...
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Significant physical or psychological conditions that could affect study compliance
- Having only one kidney or a kidney transplant
- Recent blood or plasma donation within specified timeframes prior to first IP administration
- Fever or symptomatic infection within 2 weeks before dosing
- Infections requiring intravenous antibiotics within 6 months prior to screening
- Positive tests for hepatitis B, hepatitis C, or HIV
- History of life-threatening infections
- Recent live vaccinations within 4 weeks prior to first IP dose
- Poor venous access or history of severe allergic reactions to investigational product
- History of malignancy except certain skin cancers or cervical conditions successfully treated
- Abnormal ECG or vital signs considered clinically significant
- Conditions or treatments causing significant immunosuppression
- Low blood magnesium or potassium levels at screening
- Active urinary tract infection
- Positive drug or alcohol screening or substance abuse history
- Excessive alcohol consumption beyond defined limits
- Use of investigational drugs or devices within 30 days prior to first IP
- Use of certain prescription or over-the-counter medications without approval
- Unwillingness to avoid strenuous exercise during specified periods
- Use or anticipated use of Tolvaptan or metformin within 30 days prior to first IP (ADPKD participants)
- Presence of other renal or systemic diseases or confounding genetic mutations (ADPKD participants)
- Renal complications such as cyst rupture or infection within 6 weeks prior to dosing
- Moderate or higher severity urinary abnormalities at screening
- Anything considered by the investigator to jeopardize safety or study integrity
AI-Screening
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Trial Site Locations
Total: 10 locations
1
South Coast Renal, Brockway House, Level 1, Suite 8, 82-86 Queen Street,
Southport, Gold Coast, Australia, 4125
Actively Recruiting
2
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Not Yet Recruiting
3
Liverpool Hospital, Clinic G-Reception 133, Level 1, Clinical Building, Burnside Drive
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
4
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
5
Westmead Hospital, Clinical Research Unit, Level 6, B Wing/Building, Hawkesbury Road
Westmead, New South Wales, Australia, 2145
Actively Recruiting
6
Mater Hospital Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
7
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3056
Actively Recruiting
8
Sunshine Hospital, Western Centre for Health Research and Education, Level 3, 176-190 Furlong Road
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
9
Linear Clinical Research
Joondalup, Western Australia, Australia, 6027
Actively Recruiting
10
Pacific Clinical Research Network Auckland
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
Research Team
S
Sreenivasu Mudumba Chief Research & Development Officer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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