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To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maximum therapeutic dose of ATX-101 | Active Comparator | ATX-101 10 mg/ml |
|
| Supratherapeutic dose of ATX-101 | Active Comparator | ATX-101 20 mg/ml |
|
| Moxifloxacin | Active Comparator | moxifloxacin (400mg) |
|
| Placebo vehicle | Placebo Comparator | placebo vehicle (PBS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATX-101 (10 mg/ml) | Drug |
| ||
| ATX-101 (20 mg/ml) |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF) | The primary endpoint will be the mean change between time-matched measurements of QTcF for ATX-101 and placebo after baseline adjustment calculating the upper bound of the one-sided 95% confidence interval. A negative TQT study can be claimed if each upper bound of the one-sided 95% CI is below 10 msec. | 2.5 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate change from placebo and baseline of the maximum therapeutic and supratherapeutic doses of ATX-101 treatment on QT interval corrected for individuals | 2.5 days |
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Inclusion Criteria:
Males or nonpregnant, nonlactating females who are aged 18 to 65 years (inclusive). Females must have a negative serum human chorionic gonadotropin (hCG) test result from a sample obtained during the screening period and after admission to the research facility, but before the dose of study material. Females of postmenopausal status must not have had menses for at least one year and if younger than 55 years of age must have a serum FSH level ≥ 35 mIU/mL. Females of childbearing potential must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
Body Mass Index (BMI) in the range of 20 - 38 kg/m2 (inclusive). Refer to Appendix A.
Presence of sufficient submental fat into which 25 subcutaneous injections spaced on a 1.0-cm grid can be safely administered based on the investigator's judgment.
Normal vital signs after 10 minutes resting in a supine position:
Normal Resting ECG
Serum hemoglobin test result of 11.0 g/dL or greater and negative hepatitis B, hepatitis C, and HIV test result within 28 days before the dose of study material.
Willing and able to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
Medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 28 days before dosing with study material for which the investigator identifies no clinically significant abnormality.
Signed informed consent obtained before any study-specific procedure is conducted.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Royce Morrison, MD, PhD | Comprehensive Clinical Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development | Miramar | Florida | 33027 | United States |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
|
| Moxifloxacin (400 mg) | Drug |
|
| Placebo vehicle (PBS) | Drug |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |