NCT05942625

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• IgA Nephropathy
• Focal Segmental Glomerulosclerosis

Interventions

Type	Name	Description
DRUG	HS-10390 tablet	Oral administration of specified dose of HS-10390
DRUG	Placebo tablet	Oral administration of matching dose ofplacebo

Timeline

• Start date: 2023-05-23
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2023-07-12
• Last updated: 2024-10-09

Locations

1 site across 1 country: China