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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04668352




Registration number
NCT04668352
Ethics application status
Date submitted
8/12/2020
Date registered
16/12/2020
Date last updated
23/06/2021

Titles & IDs
Public title
A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
Scientific title
A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
Secondary ID [1] 0 0
RTB-101-204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dactolisib
Other interventions - Placebo

Experimental: Dactolisib 10mg once daily -

Placebo Comparator: Placebo -


Treatment: Drugs: Dactolisib
TORC1 inhibitor

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With Clinically Symptomatic Respiratory Illness
Timepoint [1] 0 0
Week 0-16

Eligibility
Key inclusion criteria
1. Written informed consent must be obtained before any assessment is performed.

2. Male and female subjects who, in the clinical judgement of the Investigator, are
without unstable medical conditions defined as conditions that require acute medical
intervention or ongoing adjustments of concomitant medications (as determined by
medical history, current concomitant medications and laboratory test results at
Screening, and physical examination, electrocardiogram (ECG) and vital signs at
Screening and Baseline).

3. Subjects must be =65 years of age.

4. 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.

5. Females must be post-menopausal. Women are considered postmenopausal and not of
childbearing potential if they have had:

- 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
profile (e.g., age appropriate, history of vasomotor symptoms) OR

- Surgical bilateral oophorectomy (with or without hysterectomy), total
hysterectomy or tubal ligation at least 6 weeks prior to Screening. In the case
of oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow up hormone level assessment will she be considered not of
childbearing potential.

6. 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. A condom is required to be used also by
vasectomized men with a partner of child-bearing potential to prevent delivery of the
drug via seminal fluid.

7. Subject must weigh at least 40 kg.

8. Subject must be able to communicate well with the Investigator, and to understand and
comply with the requirements of the study including completing a daily eDiary at home.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any subject who:

- Is a current smoker as assessed by medical history or a positive serum cotinine
test (or positive urine cotinine test if serum cotinine testing is unavailable)
at Screening. Stopped smoking =1 year prior to Screening.

- Is a previous smoker with a =10 pack year smoking history. Has a household member
who currently smokes in the house

2. Subjects with a medical history of clinically significant lung diseases other than
asthma (e.g., chronic obstructive pulmonary disease (COPD), emphysema, interstitial
pulmonary fibrosis (IPF), bronchiectasis, etc.).

3. Subjects with a Mini Mental Status Examination (MMSE) score <24 at Screening.

4. Subjects with current evidence of a serious and/or unstable medical disorder including
cardiovascular, respiratory, gastrointestinal, renal (including subjects with an
estimated glomerular filtration rate (eGFR) as estimated by the modified diet in renal
disease (MDRD) GFR equation that is =30 mL/min/1.73m2), or hematologic disorders.

5. The following cardiac conditions:

- Unstable angina pectoris or acute ischemic changes on ECG at Screening or
Baseline

- History of myocardial infarction (MI), coronary bypass surgery, or any
percutaneous coronary intervention (PCI) within 6 months prior to Screening

- New York Heart Association functional classification IIIIV congestive heart
failure

- Unstable or life-threatening cardiac arrhythmia, chronic stable atrial
fibrillation is allowed.

- QTcF>480 msec at Screening or Baseline

6. Subjects with history of malignancy in any organ system within the past 5 years,
EXCEPT for the following:

- Localized basal cell or squamous cell carcinoma of the skin.

- Prostate cancer confined to the gland (AJCC stage T2N0M0 or better).

- Cervical carcinoma in situ.

- Breast cancer localized to the breast.

7. Any RTI or acute significant illness (based on the subject's medical history and the
clinical judgement of the Investigator) which has not resolved at least two (2) weeks
prior to Baseline.

8. Subjects with a history of systemic autoimmune diseases (e.g., lupus, inflammatory
bowel disease, rheumatoid arthritis, etc.), or receiving immunosuppressive therapy
(such as mycophenolate, tacrolimus, cyclosporine, azathioprine, infliximab) including
chronic use of prednisone >10 mg daily (however, inhaled corticosteroids and the acute
use of higher doses of prednisone to treat conditions such as exacerbation of asthma
or other acute conditions are allowed).

9. Subjects with Type I diabetes mellitus.

10. Clinically relevant abnormal laboratory values suggesting an unknown disease and
requiring further evaluation.

11. Subjects with any one of the following during Screening:

- white blood cell (WBC) count <2.0 x103/microL.

- neutrophil count <1.0 x 103/microL.

- platelet count <75 x 103/microL..

12. Subjects with a history of alcohol or drug abuse within 2 years of the Screening
visit.

13. Subjects with any conditions affecting absorption, distribution, or metabolism of the
study drug (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or hepatic
disease). For subjects with biochemical evidence of liver injury as indicated by
abnormal liver function tests:

- Any single parameter of alanine aminotransferase (ALT), aspartate
aminotransferase (AST), alkaline phosphatase or serum bilirubin must not exceed
1.5 x upper limit of normal (ULN) in subjects who do not have Gilbert's syndrome.
If the subject has a history of Gilbert's syndrome, direct and indirect reacting
bilirubin should be differentiated, and the direct bilirubin must be less than
1.5 x ULN.

- Any elevation above ULN of more than one parameter of ALT, AST, alkaline
phosphatase or serum bilirubin will exclude a subject from participation in the
study.

14. Subjects with a history of immunodeficiency diseases, including a positive human
immunodeficiency virus (HIV) test result.

15. Infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV).

16. Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or
subjects who require treatment with digoxin.

17. Use of any other investigational medication or participation in any other
investigational study within 5 half-lives of the investigational medication, or within
30 days, whichever is longer; or longer if required by local regulations.

18. Subjects who have received an organ transplant.

19. Subjects who previously received treatment with RTB101 in another clinical study
(e.g., CBEZ235Y2201, RTB-BEZ235-202, or RTB-101-203).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/12/2019
Sample size
Target
Accrual to date
Final
1024
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Restorbio Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine if RTB101 as compared to placebo decreases the percentage of subjects with
clinically symptomatic respiratory illness (with or without an associated
laboratory-confirmed pathogen) through Week 16.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04668352
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dean Quinn, MD
Address 0 0
P3 Research Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries