NCT05638126

Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects

A Phase I Single and Multiple Ascending Dose and Food Effect Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-1780 Tablets in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	HRS-1780 table or placebo	HRS-1780 table or placebo single dose
DRUG	HRS-1780 table or placebo	HRS-1780 table or placebo single dose with food effect
DRUG	HRS-1780 table or placebo	HRS-1780 table or placebo multiple dose

Timeline

• Start date: 2023-02-02
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-12-06
• Last updated: 2023-10-25

Locations

1 site across 1 country: China