Healthy Adult Subjects
Conditions
Keywords
ONO-6950, Healthy adult subjects
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.
Interventions
DRUGONO-6950
30 mg, 100 mg, 300 mg at multiple doses
Sponsors
Ono Pharma USA Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed