A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 10xBio, LLC
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.
详细描述
About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subject is a male or non-pregnant female 18-65 years of age
- •Signed informed consent
- •Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline
- •Subject is in good general health
排除标准
- •Loose skin or prominent platysmal bands in the neck or chin area
- •Recent treatment with anticoagulants
- •Presence of clinically significant health problems
研究组 & 干预措施
10XB-101 Solution for Injection 1.25%
Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Solution for Injection 2.0%
Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Solution for Injection 3.0%
Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Solution for Injection 4.5%
Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Solution for Injection 6.0%
Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
干预措施: 10XB-101 Solution for Injection (Drug)
结局指标
主要结局
Adverse Events
时间窗: 24 weeks
Incidence (severity and causality) of any local and systemic Adverse Events
Local Skin Reactions (LSR)
时间窗: 24 weeks
At each time point, the number of subjects with presence (and severity) of the following LSRs on a 4 point scale (zero to 3), with a higher score indicating a worse outcome: erythema, edema, tenderness on palpation, bruising, pain, and stinging/burning
次要结局
- Clinician Submental Fat Scale (CSFS)(24 weeks)
- Patient Submental Fat Scale (PSFS)(24 weeks)