Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
- Registration Number
- NCT01405651
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy non-smoking male or female subjects (18-55 inclusive)
- Body mass index (BMI)of 10-35 kg/m2 (inclusive)
- For females; postmenopausal, non-lactating, and non-pregnant
Exclusion Criteria
- History or presence of clinical significant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E ONO-6950 ONO-6950 P ONO-6950 Placebo
- Primary Outcome Measures
Name Time Method Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations At protocol-specified timepoints before and after study drug administration up to 21 days
- Secondary Outcome Measures
Name Time Method Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests At protocol-specified timepoints before and after study drug administration up to 21 days
Trial Locations
- Locations (1)
Miramar Clinical Site
🇺🇸Miramar, Florida, United States