Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPYC Therapeutics
About this trial
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 criteria
Qualifiers
At the discretion of the PI or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening
BMI ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg.
Non-smoker and must not have used any tobacco or nicotine products within 2 months prior to Screening.
Clinical laboratory values within normal range or deemed not clinically significant by the PI
Disqualifiers
Females who are pregnant, breastfeeding, or plan to become pregnant during the course of the study.
Underlying physical or psychological medical condition that, in the opinion of the PI or designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
Has only 1 kidney or has received a kidney transplant.
Blood donation or had significant blood loss (> 500 mL) within 30 days prior to the first administration of IP.
Trial design
Treatments tested in this trial
- PYC-003
Treatment groups
166 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov