A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Oct 2026 to Aug 4, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised
  2. Recruitment opened
    • Start date changed from estimate of Jan 2026 to Jan 13, 2026
    • Eligibility criteria revised
    • Site details revised
    v2
  3. Study First Submitted
  • 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.
The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
Trial Details
NCT Number NCT07322016
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions
(from sponsor)		 Hyperlipidemias
Related terms Hyperlipidemias
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov