drugset / Trial / NCT05119972

Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT05119972 ↗

Phase 1/2 Completed 15 enrolled Guangdong Raynovent Biotech Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.

Timeline

Start
2021-10-21
Primary completion
2023-12-21
Completion
2023-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject ZSP1603 Unknown — Oral