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The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to compare the pharmacokinetic profile of ATX-101 administered into subcutaneous fat in the submental area and abdomen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATX-101 in abdomen area | Experimental | Crossover study in which subjects will receive 2 mg/cm2 ATX-101 in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session |
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| ATX-101 in submental area | Experimental | Crossover study in which subjects will receive 2 mg/cm2 ATX-101 in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATX-101 | Drug | 2 mg/cm2 ATX-101 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ATX-101 injections as assessed by incidence, severity and duration of AEs of ATX-101 administered into subcutaneous fat in the submental and abdomen area | This is a single center, open-label, crossover study in which subjects will receive 2 mg/cm2 ATX-101 as indicated below in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session. For the first dosing session dosing will occur on Day 0 with the 2nd dosing session occurring on Day 8. A final follow-up visit will occur on Day 14. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the pharmacokinetic profile (Cmax, tmax, AUC, half-life) of ATX-101 administered into subcutaneous fat in the submental and abdomen area | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Walker, MD, PhD | Kythera Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Fargo | North Dakota | 58104 | United States |
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