Status:
COMPLETED
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any assessment is performed.
- 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.
- 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.
- Oxygen saturation (O2) at screening must be ≥ 95% on room air.
- FEV1 ≥ 90% predicted.
Exclusion
- 1\. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening.
- History of asthma or reactive airway diseases.
- Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL.
- 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.
- Women of child-bearing potential
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02245828
Start Date
July 1 2014
End Date
December 1 2015
Last Update
March 22 2016
Active Locations (1)
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1
Novartis Investigative Site
Mid Glamorgan, Wales, United Kingdom, CF484DR