Clinically Symptomatic Respiratory Illness
Conditions
Keywords
Mechanistic Target of Rapamycin (mTOR), Influenza, Virus, Pneumonia, Immunosenescence, Respiratory Tract Infections
Brief 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.
Interventions
DRUGDactolisib
TORC1 inhibitor
DRUGPlacebo
Placebo capsule
Sponsors
Restorbio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with clinically symptomatic respiratory illness | Through Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with clinically symptomatic respiratory illness associated with ≥1 laboratory-confirmed pathogen(s) | Through Week 16 | — |
| Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) | Through Week 16 | — |
| Rate of clinically symptomatic respiratory illnesses associated with ≥1 laboratory-confirmed pathogen(s) | Through Week 16 | — |
| Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness | Through Week 16 | — |
| Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses | Through Week 16 | — |
| Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 | Through Week 20 | — |
| Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses | Through Week 16 | 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. |
Outcome results
None listed