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A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.
A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: ONO-4474 Part A1 | Experimental | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Placebo Part A1 | Placebo Comparator | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Part A2 | Experimental | Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Placebo Part A2 | Placebo Comparator | Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Part B | Experimental | Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Placebo Part B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4474 Part A1 | Drug | Healthy volunteers |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of ONO-4474 (Cmax) | Day 1 and at Day 7 | |
| ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24) | Day 1 and at Day 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drug Development Division | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Clinical Site | Aalborg | Denmark | ||||
| Nottingham Clinical SIte |
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Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Part C | Experimental | NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design |
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| Experimental: ONO-4474 Placebo Part C | Placebo Comparator | NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design |
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| Experimental: ONO-4474 Part D | Experimental | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Experimental: ONO-4474 Placebo Part D | Placebo Comparator | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
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| Placebo Part A1 | Drug | Healthy volunteers |
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| ONO-4474 Part A2 | Drug | Healthy volunteers |
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| Placebo Part A2 | Drug | Healthy volunteers |
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| ONO-4474 Part B | Drug | Healthy volunteers |
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| Placebo Part B | Drug | Healthy volunteers |
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| ONO-4474 Part C | Drug | Healthy volunteers |
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| Placebo Part C | Drug | Healthy volunteers |
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| ONO-4474 Part D | Drug | Healthy volunteers |
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| Placebo Part D | Drug | Healthy volunteers |
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| Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474 |
| Day 1 and at Day 7 |
| Plasma Decay half life (T1/2) of ONO-4474 | Day 1 and at Day 7 |
| Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale | 3hr and 24hr after NGF injection |
| Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection. | Pressure algometry at site of NGF injection (anterior tibialis) | 3hr and 24hr after NGF injection |
| Nottingham |
| United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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