NCT04139915

Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly

A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Restorbio Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age.

Detailed description

RTB-101-205 is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, Phase 3 study to determine if RTB101, a selective TORC1 inhibitor, prevents illness associated with respiratory tract infections (defined as clinically symptomatic respiratory illness) in adults ≥65 years of age. This trial is being conducted in follow up to two Phase 2 trials in older adults in which RTB101 10 mg administered once daily for up to 16 weeks during winter cold and flu season was observed to reduce the incidence of respiratory illness associated with respiratory tract infections.

Conditions

• Clinically Symptomatic Respiratory Illness

Interventions

Type	Name	Description
DRUG	Dactolisib	TORC1 inhibitor
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2019-10-21
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2019-10-25
• Last updated: 2019-11-22

Regulatory

• FDA-regulated drug study