Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04139915 |
Recruitment Status :
Withdrawn
(Phase 3 trial RTB-101-204 study did not meet its primary endpoint)
First Posted : October 25, 2019
Last Update Posted : November 22, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clinically Symptomatic Respiratory Illness | Drug: Dactolisib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly |
Actual Study Start Date : | October 21, 2019 |
Actual Primary Completion Date : | November 15, 2019 |
Actual Study Completion Date : | November 15, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: 10 mg daily RTB101
Oral RTB101 10 mg hard gelatin capsule once daily for 16 weeks
|
Drug: Dactolisib
TORC1 inhibitor
Other Names:
|
Placebo Comparator: Placebo
Oral matching placebo once daily for 16 weeks
|
Drug: Placebo
Placebo capsule |
- Percentage of subjects with clinically symptomatic respiratory illness [ Time Frame: Through Week 16 ]
- 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 [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139915
Study Director: | Medical Director | Restorbio Inc. |
Responsible Party: | Restorbio Inc. |
ClinicalTrials.gov Identifier: | NCT04139915 |
Other Study ID Numbers: |
RTB-101-205 |
First Posted: | October 25, 2019 Key Record Dates |
Last Update Posted: | November 22, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Mechanistic Target of Rapamycin (mTOR) Influenza Virus |
Pneumonia Immunosenescence Respiratory Tract Infections |
Respiratory Tract Infections Infections Respiratory Tract Diseases Dactolisib Antineoplastic Agents |