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| Name | Class |
|---|---|
| Simbec Research | INDUSTRY |
| ORION Clinical Services | INDUSTRY |
| Packaging Coordinators Inc | OTHER |
| Centro de BiologÃa Molecular Severo Ochoa, Spain (CBMSO) |
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo |
|
| Cohort B | Experimental | Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AX-024.HCl | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | Over a 72 hours period and 7 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve | Over a 72 hours period post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girish Sharma, MBBS | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research Ltd | Merthyr Tydfil | Cardiff Road | CF48 4DR | United Kingdom |
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| UNKNOWN |
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