A Phase 1 Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.
研究概览
简要总结
Dose-ranging, randomized, double-blind, vehicle-controlled study
详细描述
Subject will receive a single injection for each treatment which all 3 test article concentrations and both injection volumes and the vehicle for a total of 7 treatments.
Subjects will receive test articles in 3 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind (investigator & subjects)
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
- •To enter the study, a subject must meet the following criteria:
- •Subject is a male or non-pregnant female 18-65 years of age.
- •Subject has provided written informed consent.
- •Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 3/Baseline.
- •Subject has agreed to undergo an abdominoplasty procedure, participate in this study, has minimally acceptable adipose tissue in the target areas per protocol, and meets all pre-operative requirements, in the opinion of the investigator and surgeon.
排除标准
- •A subject is ineligible to enter the study if he/she meets one or more of the following criteria:
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has a significant active systemic or localized abdominal infection.
- •Subject has a body mass index (BMI) ≥
- •Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
- •Subject is taking any medications that affect clotting and/or platelet function. This includes, but is not limited to, heparin (including low molecular weight heparin), Coumadin, and factor Xa agents such as apixaban (Eliquis), etc. The use of such medications is precluded up to 7 days prior to Visit 3/Baseline and during the study period.
- •Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., HIV positive, malignancy), medication use, or other factors.
- •Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism or excretion.
- •Subject has local skin condition(s) (e.g., rash, scarring, and tattoos) or inadequate injection sites in the region designated for abdominoplasty excision which are inappropriate for participation in the study, in the opinion of the investigator.
- •Subject is currently enrolled in an investigational drug, biologic, or device study.
- •Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to first injection of the test article.
- •Subject has a history of sensitivity to any of the ingredients in the test articles (see Section 6.1).
- •Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
研究组 & 干预措施
STP705, 120ug/mL, 0.5 cc
Volume of Injection 0.5cc
干预措施: STP705 (Drug)
STP705, 120ug/mL, 1.0 cc
Volume of Injection 1.0cc
干预措施: STP705 (Drug)
STP705, 240 ug/mL, 0.5 cc
Volume of Injection 0.5cc
干预措施: STP705 (Drug)
STP705, 240ug/mL, 1.0 cc
Volume of Injection 1.0cc
干预措施: STP705 (Drug)
STP705, 320ug/mL, 0.5 cc
Volume of Injection 0.5cc
干预措施: STP705 (Drug)
STP705, 320ug/mL, 1.0 cc
Volume of Injection 1.0cc
干预措施: STP705 (Drug)
Vehicle
1.0cc placebo
干预措施: STP705 (Drug)
结局指标
主要结局
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.
时间窗: 24 weeks
LSR scale will be used by investigator to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, limited involvement, 2= moderate involvement, and 3= severe, extreme involvement)
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning.
时间窗: 24 weeks
LSR scale will be used by subjects to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, 2= moderate, and 3= severe)
Incidence (severity and causality) of any AEs
时间窗: 24 weeks
AE's will be classified using CTCAE v.5.0
次要结局
未报告次要终点