Pure Global
NCT06135363

Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers
Guangzhou JOYO Pharma Co., Ltd·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Idiopathic Pulmonary Fibrosis
Drug/Device/Intervention
SC1011
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Guangzhou JOYO Pharma Co., Ltd
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 1
Start date
Aug 11, 2022
End date
Jan 14, 2023
Enrollment
45 participants
Primary outcome

Incidence and severity of adverse events and serious adverse events related drug.

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.

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06135363
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06135363 through Pure Global AI's free database. This Phase 1 trial is sponsored by Guangzhou JOYO Pharma Co., Ltd and is currently Completed. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 45 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.