An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients
Status and phase
Terminated
Phase 1
Conditions
Chronic Obstructive Pulmonary Disease
Treatments
Drug: Placebo
Drug: TV48108
Details and patient eligibility
About
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.
Enrollment
61 patients
Sex
All
Ages
20 to 75 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
61 participants in 5 patient groups, including a placebo group
TV48108 - Healthy Volunteers
Experimental group
Description:
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
Treatment:
Drug: TV48108
Placebo - Healthy Volunteers
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
TV48108 15 µg COPD
Experimental group
Description:
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.
Treatment:
Drug: TV48108
TV48108 60 µg COPD
Experimental group
Description:
Stage 2
Treatment:
Drug: TV48108
TV48108 120 µg COPD
Experimental group
Description:
Stage 2 .
Treatment:
Drug: TV48108
Trial contacts and locations
7
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Data sourced from clinicaltrials.gov
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