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

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Placebo

Drug: QCC374

Study type

Interventional

Funder types

Industry

Identifiers

NCT02245828

CQCC374X2101

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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