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A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of GLR1075 Injection in Healthy Trial Participants and Cirrhotic Trial Participants With Ascites and Hypoalbuminemia

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is conducted in China. This study plans to include 3 parts,Part A, a single ascending dose (SAD) study in healthy trial participants; Part B, a multiple dose (MD) study in healthy trial participants; and Part C, a multiple ascending dose (MAD) study in cirrhotic trial participants with ascites and hypoproteinemia. All parts are intended to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of GLR1075.
Trial Details
NCT Number NCT07851688
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Hypoalbuminemia in Cirrhotic Ascites
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov