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

resTORbio

Status and phase

Withdrawn

Phase 3

Conditions

Clinically Symptomatic Respiratory Illness

Treatments

Drug: Placebo

Drug: Dactolisib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04139915

RTB-101-205

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must be ≥65 years of age
Subjects should require no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible
Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period

Exclusion criteria

Subjects who are current smokers, stopped smoking ≤ 1 year prior to screening, or have and a ≥ 10 pack year smoking history
Subjects with a medical history of clinically significant lung diseases (including COPD) other than asthma
Subjects with current evidence of a serious and/or unstable medical disorder
Subjects with unstable cardiac conditions
Subjects with a history of systemic autoimmune diseases
Subjects with Type I diabetes mellitus
Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result
Infection with Hepatitis B (HBV) or Hepatitis C (HCV)