Healthy Subjects
Conditions
Keywords
healthy subjects, inhaled
Brief summary
This is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. Safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be drawn at specified timepoints.
Interventions
DRUGQCC374
Single and multiple ascending doses of QCC374
DRUGPlacebo
Placebo comparator
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed. 2. Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 3. Weight of at least 50 kg and body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2. 4. Oxygen saturation (O2) at screening must be ≥ 95% on room air. 5. FEV1 ≥ 90% predicted.
Exclusion criteria
1. 1\. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening. 2. History of asthma or reactive airway diseases. 3. Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL. 4. History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 5. Women of child-bearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 39 days | Number of Participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | 39 days | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration |
| AUCtau | 39 days | The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau |
| Cav | 39 days | The average steady state plasma concentration during multiple dosing |
| AUCinf | 39 days | Area under the plasma concentration-time curve from time zero to infinity |
| T1/2 | 39 days | The terminal elimination half life |
| Tmax | 39 days | The time to reach the maximum concentration after drug administration |
| Cmax | 39 days | The observed maximum plasma concentration following drug administration |
Countries
United Kingdom
Outcome results
None listed