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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental | ONO-6950 |
|
| P | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-6950 | Drug | 30 mg, 100 mg, 300 mg at multiple doses |
| |
| ONO-6950 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miramar Clinical Site | Miramar | Florida | 33025 | United States |
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| ID | Term |
|---|---|
| C000603360 | gemilukast |
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| Drug |
Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950 |
|