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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Study sites: 10 to 12v17
  2. Primary completion pushed from Sep 2026 to Nov 2028v16 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 116 → 166 participants
    • Study completion pushed from Mar 2027 to Nov 2028
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (10)
    • Study description shortened, about 16 words
  3. Study sites: 9 to 10v15
  4. Enrollment target: 56 to 116v14 Show 8 more changesShow less
    • Primary completion date: Jan 2026 to Sep 2026
    • Primary endpoints: 14 to 18
    • Study sites: 6 to 9
    • Study completion date: Jan 2026 to Mar 2027
    • Eligibility criteria expanded, about 1,586 words
    • Secondary endpoints: 9 to 10
    • Study description expanded, about 100 words
    • Study arms: 2 to 3
  5. Eligibility criteria shortened, about 1,610 words
    • Secondary endpoints reordered
    • Study sites revised (6)
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Site details revised at 4 of 6 sitesv12
  2. Site contacts updated at 1 of 6 sitesv11
  3. Site details revised at 6 of 6 sitesv10
  4. Primary endpoints: 19 to 14
    • Study sites: 5 to 6
    • Eligibility criteria shortened, about 124 words
    • Secondary endpoints revised (9)
    v9
  5. Site details revised at 5 of 5 sitesv8
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Apr 2025 to Apr 7, 2025
    v7
  7. Re-verified, no change to tracked fieldsv6
  8. Primary endpoints: 27 to 19v5 Show 5 more changesShow less
    • Enrollment target: 60 to 56
    • Eligibility criteria shortened, about 88 words
    • Secondary endpoints: 19 to 9
    • Study description expanded, about 149 words
    • Study arms: 3 to 2
  9. Primary and study completion dates: Jan 2027 to Jan 2026
    • Secondary endpoints: details revised at 19 of 19 entries
    v4
  10. 2 versions Re-verified since Jan 28, 2025, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06714006
Lead Sponsor PYC Therapeutics
Conditions
(from sponsor)		 Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Related terms Polycystic Kidney, Autosomal Dominant
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov