Dose-Escalation Safety and Pharmacokinetic Study of ATX-101
- Registration Number
- NCT00618709
- Lead Sponsor
- Kythera Biopharmaceuticals
- Brief Summary
The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy males or nonpregnant females
- Age 18 to 65
- Sufficient submental fat for injections
- Signed informed consent
Exclusion Criteria
- Prior interventions in the chin or neck area
- History or presence of drug or alcohol abuse
- Treatment with an investigational agent within 30 days before the dose
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 ATX-101 ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid Cohort 1 ATX-101 ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid Cohort 3 ATX-101 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 Cohort 4 ATX-101 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
- Primary Outcome Measures
Name Time Method Safety assessed by: medical evaluations 24 weeks Safety assessed by: ECG results 24 weeks Safety assessed by: Laboratory tests 12 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profile 24 hours, before and after dosing Cmax, tmax, AUC
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Tempe, Arizona, United States