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Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers

Clinical Trial Summary

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.

Clinical Trial Description

This is a single-center, open label study to evaluate the safety，tolerability and pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2 groups. Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1, twice daily on days 2-6 and once within half an hour after breakfast on day 7 . Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days, with dosing consisting of one dose within half an hour after breakfast on day 1, twice daily on days 2-6, and once within half an hour after breakfast on day 7. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06135363
Study type Interventional
Source Guangzhou JOYO Pharma Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date August 11, 2022
Completion date January 14, 2023
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