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The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects.

Pulmonary Fibrosis Clinical Trial

Official title:
A Phase I, Single-center, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Tolerability, Pharmacokinetic, and Food Effect Study of SC1011 in Healthy Volunteers

Clinical Trial Summary

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy subjects.Food effect in healthy subjects.Participants will complete the study including screening period, dosing period, and observation period. Researchers 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 double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Part B will comprise a multiple-dose, sequential-group study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06160440
Study type Interventional
Source Guangzhou JOYO Pharma Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date June 3, 2021
Completion date February 23, 2022
View Details
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