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

Restorbio Inc.

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Clinically Symptomatic Respiratory Illness

Interventions

DactolisibDRUG

TORC1 inhibitor

PlaceboDRUG

Placebo capsule

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percentage of subjects with clinically symptomatic respiratory illness

Time frame: Through Week 16

Secondary Outcomes

Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s)

Time frame: Through Week 16

Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen)

Time frame: Through Week 16

Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s)

Time frame: Through Week 16

Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness

Time frame: Through Week 16

Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses

Time frame: Through Week 16

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

Time frame: Through Week 20

Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses

Descriptive statistics will be provided for the rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses. No formal statistical tests will be conducted.

Time frame: Through Week 16

Data from ClinicalTrials.gov

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