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| ID | Type | Description | Link |
|---|---|---|---|
| ATX-101-07-08 |
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The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101
This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid |
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| Cohort 2 | Experimental | ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid |
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| Cohort 3 | Experimental | 3 subgroups in Cohort 3: 3a: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 3b: ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 3c: ATX-101 (2 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid |
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| Cohort 4 | Experimental | 3 subgroups in Cohort 4: 4a: ATX-101 (8 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 4b: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 4c: ATX-101 (4 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATX-101 | Drug | ATX-101 single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by: Laboratory tests | 12 weeks | |
| Safety assessed by: medical evaluations | 24 weeks | |
| Safety assessed by: ECG results | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile | Cmax, tmax, AUC | 24 hours, before and after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessed by visual analog scale | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Swearingin, M.D. | MDS Pharma Services | Principal Investigator |
| Frederick Beddingfield, M.D. | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Tempe | Arizona | 85283 | United States |
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