NCT05523739

Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients

A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study Evaluating the Safety of a Single Ascending Dose of STI-1558 in Healthy Subjects and the Safety, Pharmacokinetics, and Efficacy of Multiple Ascending Doses of STI-1558 in SARS-CoV-2-Positive Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of STI-1558 in healthy subjects and the safety, pharmacokinetics, and efficacy in SARS-CoV-2-Positive subjects.

Detailed description

This is a two-part, randomized, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics (PK) of a single ascending dose of STI-1558 in healthy subjects and the safety, PK and efficacy of a multiple ascending dose in SARS-CoV-2-positive subjects.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	STI-1558	An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro).

Timeline

• Start date: 2022-09-16
• Primary completion: 2022-12-21
• Completion: 2023-03-29
• First posted: 2022-08-31
• Last updated: 2023-08-14

Locations

1 site across 1 country: China