A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly

NCT04668352 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RTB-101-204
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Clinically Symptomatic Respiratory Illness

  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

  Week 0-16

Study Arms (2)

Dactolisib 10mg once daily

EXPERIMENTAL

Drug: Dactolisib

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Dactolisib DRUG

TORC1 inhibitor

Dactolisib 10mg once daily

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• 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).
• 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.
• Females must be post-menopausal. Women are considered postmenopausal and not of childbearing potential if they have had:
• 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.
• 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.
• Subject must weigh at least 40 kg.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Restorbio Inc.: lead

Study Sites (1)

P3 Research Ltd.

Wellington, New Zealand

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

dactolisib

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Nick Harvey
• Organization: Adicet Bio

nharvey@adicetbio.com

857-315-5528

Study Officials

• Dean Quinn, MD

  P3 Research Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: April 15, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-05

Locations

NZ (1)