A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500
研究概览
简要总结
A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7 non-pivotal studies were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- •Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- •Were naive to AA4500 treatment.
- •Were judged to be in good health.
排除标准
- •Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- •Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
- •Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
研究组 & 干预措施
AA4500 0.58 mg
干预措施: collagenase clostridium histolyticum (Biological)
结局指标
主要结局
Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500
时间窗: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30
AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).
次要结局
- Percent Change From Baseline Contracture(Baseline, 30 days after treatment to the primary joint)
- Change From Baseline Range of Motion(Baseline, 30 days after treatment to the primary joint)
- Clinical Improvement(30 days after treatment to the primary joint)
- Clinical Success(30 days after treatment to the primary joint)