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A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

IgA Nephropathy Clinical Trial

Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects

Clinical Trial Summary

The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.

Clinical Trial Description

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05942625
Study type Interventional
Source Hansoh BioMedical R&D Company
Contact Bicheng Liu
Phone 18001580838
Email liubc64@163.com
Status Recruiting
Phase Phase 1
Start date May 23, 2023
Completion date February 16, 2024
View Details
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