A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH
研究概览
简要总结
To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be adequately informed and understand the nature and risks of the study and be able to provide consent.
- •Be undergoing planned elective abdominoplasty.
- •Be willing to have their tissue donated for evaluation.
- •Be judged to be in good health.
- •Have a negative pregnancy test.
- •Be willing and able to cooperate with the requirements of the study.
排除标准
- •Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
- •Has local (in the areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- •Required use of anticoagulant or antiplatelet medication (except ≤ 150 mg aspirin daily) before or during participation in the trial.
- •Past history of any abdominal surgery, including but not limited to: liposuction, caesarean section, appendectomy, cholecystectomy, or umbilical hernia repair.
- •Has used or intends to use any local applications/therapies/injections/procedures that restricts study participation.
- •Is presently nursing or providing breast milk in any manner.
- •Intends to become pregnant during the study.
- •Intends to initiate an intensive sport or exercise program regimen during the study.
- •Intends to use any tanning spray or tanning booths during the study.
- •Has received any investigational drug or treatment within 30 days prior to first injection of study drug.
- •Has a known systemic allergy to collagenase or any other excipient of study drug.
- •Has received any collagenase treatment at any time prior to treatment in this study.
- •Any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
研究组 & 干预措施
Group 1: CCH Single Injection Technique
Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique.
Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.
干预措施: Collagenase Clostridium Histolyticum Single Injection Technique (Drug)
Group 2: CCH Single Injection Technique
Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.
干预措施: Collagenase Clostridium Histolyticum Single Injection Technique (Drug)
Group 3: CCH Single Injection Technique
Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
干预措施: Collagenase Clostridium Histolyticum Single Injection Technique (Drug)
Group 4: CCH Multiple Injection Technique
Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.
Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.
干预措施: Collagenase Clostridium Histolyticum Multiple Injection Technique (Drug)
Group 5: CCH Multiple Injection Technique
Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.
Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.
干预措施: Collagenase Clostridium Histolyticum Multiple Injection Technique (Drug)
Group 6: CCH Multiple Injection Technique
Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.
Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
干预措施: Collagenase Clostridium Histolyticum Multiple Injection Technique (Drug)
结局指标
主要结局
Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH
时间窗: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported.
次要结局
- Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection(Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty))
- Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment(End of Study (Day 28))
- Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment(End of Study (Day 28))