drugset / Trial / NCT06160440

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

NCT06160440 ↗

Phase 1 Completed 55 enrolled Guangzhou JOYO Pharma Co., Ltd
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2021-06-03
Primary completion
2021-09-23
Completion
2022-02-23

Drugs

EvaluationDrugModalityDoseRoute
Subject SC1011 Unknown 50 mg Oral
Subject SC1011 Unknown 150 mg Oral
Subject SC1011 Unknown 300 mg Oral