An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients

Study Overview
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Brief Summary
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The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.

Official Title
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A 2-Stage, Single-Dose Study in Healthy Volunteers and COPD Patients With an Open Label Ipratropium Bromide Reference to Evaluate the Efficacy, Pharmacokinetics, and Safety Profile of Inhaled TV48108

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: TV48108
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 1 (Healthy Volunteers) Male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body mass index (BMI) of less than 30 kg/m^2. In good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology. Other criteria apply, please contact the investigator for more information Stage 2 (Chronic Obstructive Lung Disease (COPD) patients) Male or female; 40 to 75 years of age, inclusive with a minimum body weight of 40 kg Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the screening visit Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines. Other criteria apply, please contact the investigator for more information Exclusion Criteria: Stage 1 (Healthy Volunteers) History or current evidence of a clinically significant or uncontrolled disease Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs. History of severe allergy to milk protein Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded. Other criteria apply, please contact the investigator for more information Stage 2 (Chronic Obstructive Lung Disease (COPD) patients) Recent history of hospitalization due to an exacerbation of airway disease within 3 months Need for increased treatments of COPD within 6 weeks prior to the screening visit History of and/or current diagnosis of asthma Known α1 antitrypsin deficiency, active lung infections (such as tuberculosis or pneumonia), and lung cancer are absolute exclusionary conditions Other criteria apply, please contact the investigator for more information

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TV48108 - Healthy Volunteers<br>Stage 1 is a randomized, placebo-controlled, double-blind, single-dose study. Healthy subjects will be randomized to receive a single inhaled dose of TV48108 120 µg | Drug: TV48108<br>* TV48108 15, 60, 120 μg<br>* Other names: 48108;|
| Placebo Comparator: Placebo - Healthy Volunteers<br>Placebo | Drug: Placebo<br>* Placebo Comparator<br>* Other names: Matching placebo;|
| Experimental: TV48108 15 µg COPD<br>Stage 2 consists of a 2-period open-label study with an ipratropium bromide reference to evaluate the single administration of 3 ascending doses of inhaled TV48108 in COPD patients. | Drug: TV48108<br>* TV48108 15, 60, 120 μg<br>* Other names: 48108;|
| Experimental: TV48108 60 µg COPD<br>Stage 2 | Drug: TV48108<br>* TV48108 15, 60, 120 μg<br>* Other names: 48108;|
| Experimental: TV48108 120 µg COPD<br>Stage 2 . | Drug: TV48108<br>* TV48108 15, 60, 120 μg<br>* Other names: 48108;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h). |  | Day 1 (pre-dose, up to 12 hours post-dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1) |  | Day 1 (pre-dose, up to 12 hours post-dose) | 
| Percentage of Participants with Adverse Events |  | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, bronchodilation