Suspended

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

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What is being tested

Dactolisib

+ Placebo

Drug
Who is being recruted

Congenital Abnormalities+17

+ Infections

+ Influenza, Human

Over 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2019
See protocol details

Summary

Principal SponsorRestorbio Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 21, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleA Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
NCT04139915
Principal SponsorRestorbio Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesInfectionsInfluenza, HumanLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System MalformationsNervous System DiseasesNeuromuscular DiseasesHereditary Sensory and Autonomic NeuropathiesOrthomyxoviridae InfectionsPeripheral Nervous System DiseasesPneumoniaPolyneuropathiesRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesNeurodegenerative DiseasesHeredodegenerative Disorders, Nervous SystemGenetic Diseases, Inborn

Criteria

3 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks

Group II

Placebo
Oral matching placebo once daily for 16 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers