A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374

Launched by NOVARTIS PHARMACEUTICALS · Sep 17, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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