NCT05372783

Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.

Detailed description

This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	STI-9199	STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
DRUG	Placebo	Diluent solution

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2022-05-13
• Last updated: 2023-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study