🏛️ Verified NIH Record • Updated 2024-12-09

PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function (NCT06729853)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Shanton Pharma Pte. Ltd.

🩺 Plain-English Summary (8th-Grade Level)

This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (37 items).

Location: Genesis Clinical Research — Tampa, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: All subjects:
  • Female who is lactating
  • Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration
  • History of significant hypersensitivity to SAP-001 or any related products (including excipients of the formulation) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Positive screening results to HIV Ag/Ab Combo and Hepatitis B surface antigen (HBsAg)
  • Positive reflex test for Hepatitis C antibody (positive Hepatitis C antibody is allowed if HCV RNA is not detected)
  • Presence or history of any disorder that could interfere with completion of the study based on the opinion of an Investigator
  • Intake of SAP-001 or any Investigational Product (IP) in the 28 days (or 5 times the half-life of the drug, whichever is longer) prior to study drug administration
  • Have urinary incontinence without catheterization
  • Reception of blood products within 3 months prior to study drug administration
  • Donation of 50 mL or more of blood in the 28 days prior to Screening
  • Donation of 500 mL or more of blood within 56 days prior to Screening.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Genesis Clinical Research — Tampa, Florida
  • Nucleus Network Pty Ltd — Saint Paul, Minnesota

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗