Effect of RTB101 on Respiratory Illness Associated with Laboratory-Confirmed Pathogens in the Elderly
- Conditions
- Respiratory IllnessInfection - Studies of infection and infectious agentsRespiratory - Other respiratory disorders / diseasesInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12619000628145
- Lead Sponsor
- INC Research Australia Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1024
Subjects eligible for inclusion in this study must fulfill all of the following 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 (as determined by medical history, electrocardiogram (ECG) and laboratory tests at Screening, and physical examination and vital signs at Screening and Baseline).
3.Subjects must be 65 years of age or older
4.Subjects who need 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 post-menopausal and not of child bearing 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 six weeks ago. 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 child bearing 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.
Subjects will not be eligible if they meet any of the following criteria:
1.Any subject who:
a.Is a current smoker as assessed by medical history or a positive cotinine test at Screening.
b.Stopped smoking less than or equal to 1 year prior to screen
c.Is a previous smoker with a more than or equal to 10 pack year smoking history
d.Has any household member who smokes more than or equal to 1 pack per day of cigarettes
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 less than 24 at Screening.
4. Subjects with current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal (including subjects with an eGFR less than or equal to 50 mL/min/1.73m2), hematologic or other medical disorder.
5.The following cardiac conditions:
a.Unstable angina pectoris or acute ischemic changes on ECG during Screening.
b.History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening.
c.New York Heart Association functional classification III-IV congestive heart failure.
d.Unstable or life-threatening cardiac arrhythmia.
6.Subjects with history of malignancy in any organ system within the past 5 years, EXCEPT for the following:
a.Localized basal cell or squamous cell carcinoma of the skin.
b.Prostate cancer confined to the gland (AJCC stage T2N0M0 or better).
c.Cervical carcinoma in situ.
d.Breast cancer localized to the breast.
7.Any respiratory tract infection 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 initial dosing.
8.Subjects with a history of a systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), or receiving immunosuppressive therapy including chronic use of prednisone more than 10 mg daily (however, acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions is 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:
a.white blood cell (WBC) count less than 2000/mL.
b.neutrophil count less than 1000/mL.
c.platelet count less than 7500/mL..
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 patients with biochemical evidence of liver injury as indicated by abnormal liver function tests:
• Any single parameter of ALT, AST, alkaline phosphatase or serum bilirubin must not exceed 1.5 x upper limit of normal (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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method