drugset / Trial / NCT06135363

Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

NCT06135363 ↗

Phase 1 Completed 45 enrolled Guangzhou JOYO Pharma Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-08-11
Primary completion
2023-01-14
Completion
2023-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject SC1011 Unknown 300 mg —
Subject SC1011 Unknown 400 mg —