NCT06160440

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Guangzhou JOYO Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	SC1011	Each subject in the SAD groups participated in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours post dose).

Timeline

• Start date: 2021-06-03
• Primary completion: 2021-09-23
• Completion: 2022-02-23
• First posted: 2023-12-07
• Last updated: 2024-11-19

Locations

1 site across 1 country: China