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

ClinicalTrials.gov ID: NCT06729853

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT06729853. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 15, 2026, 7:03 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of SAP-001 in Adult Subjects With Normal and Impaired Renal Function

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06729853
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Shanton Pharma Pte. Ltd.; Industry
Enrollment: 32 participants

Conditions and interventions

Conditions

Interventions

SAP-001 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 24, 2024 (Actual)
Primary completion: Jan 17, 2025 (Estimated)
Completion: Apr 28, 2025 (Estimated)
Last update posted: Dec 11, 2024

2024 – 2025

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Genesis Clinical Research	Tampa	Florida	33603	—
Nucleus Network Pty Ltd	Saint Paul	Minnesota	55114	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06729853, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 11, 2024 · Synced Nov 15, 2026