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This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B after single and multiple doses in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ADC3680B vs. Placebo | Experimental |
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| Cohort 2: ADC3680B vs. Placebo | Experimental |
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| Cohort 3: ADC3680B vs Placebo | Experimental |
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| Cohort 4: ADC3680B vs. Placebo | Experimental |
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| Cohort 5: ADC3680B vs. Placebo | Experimental |
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| Cohort 6: ADC3680B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC3680B | Drug | Escalating single doses ADC3680B or Placebo over 5 study periods |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs | 2 days | |
| Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Single dose pharmacokinetics of ADC3680B | 2 days | |
| Multiple dose pharmacokinetic of ADC3680B | 8 days | |
| Pharmacokinetics of ADC3680B under fasted and fed conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Febbraro | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec | Merthyr Tydfil | CF48 4DR | United Kingdom |
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| ADC3680B | Drug | ADC3680B or Placebo for 7 days |
|
| ADC3680B | Drug | Single doses ADC3680B over 2 study periods under fasted and fed conditions |
|
| 2 days |
| Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo | Pre-dose and up to 48 hours post-dose |