Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety assessed by: Laboratory tests
研究概览
简要总结
The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or nonpregnant females
- •Age 18 to 65
- •Sufficient submental fat for injections
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
Cohort 1
ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid
干预措施: ATX-101 (Drug)
Cohort 2
ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid
干预措施: ATX-101 (Drug)
Cohort 3
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
干预措施: ATX-101 (Drug)
Cohort 4
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
干预措施: ATX-101 (Drug)
结局指标
主要结局
Safety assessed by: Laboratory tests
时间窗: 12 weeks
Safety assessed by: medical evaluations
时间窗: 24 weeks
Safety assessed by: ECG results
时间窗: 24 weeks
次要结局
- Pharmacokinetic profile(24 hours, before and after dosing)