NCT07640425招募中1 期
A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture
CONNEXT1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月23日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This trial is a multicenter, Phase 1/2, study to assess the safety, tolerability, efficacy, PK, and immunogenicity of CNT201 in adult participants with DC (Dupuytren's Contracture).
详细描述
This is an adaptive clinical study design containing 2 steps:
- Step 1 (dose escalation) is an open-label, dose escalating design where each participant will be enrolled into 1 of 4 dose levels and receive a single administration of CNT201. A Safety Review Committee (SRC) will decide on the dose escalation steps and which dose(s) will be selected to progress into Step 2 dose expansion stage.
- Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design. Eligible participants will be randomized to receive either CNT201 or a placebo for up to a total of 3 treatment cycles per cord at the discretion of the Investigator.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18 to 75 years of age, inclusive.
- •Participants with a diagnosis of DC, with a fixed flexion deformity of at least 1 finger, other than the thumb, that have a contracture at least 20°, but not greater than 100°, for MP (not greater than 80° for PIP) joints, caused by a palpable cord.
- •Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a tabletop.
- •Participants who are naive to CNT201 treatment.
- •Participants who are judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
- •Participants who are willing to voluntarily sign and date the Informed Consent Form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
排除标准
- •Participants previously exposed to collagenase Clostridium histolyticum for treatment of Dupuytren's disease (Xiaflex, Xiapex®).
- •Participants who have received other treatments for advanced Dupuytren's disease, including surgery (fasciectomy or 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 treatment.
- •Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the Investigator's opinion will make the participant unsuitable for enrollment in the study.
- •Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (eg, testing positive for tuberculosis [TB] or Coronavirus disease 2019 [COVID-19], etc), or history of alcoholism or drug abuse, which in the Investigator's opinion, would make the participant unsuitable for enrollment in the study.
- •Participants who have a known allergic response to collagenase or any other excipient of CNT201 or Xiaflex.
- •Participants who have received a doxycycline or tetracycline derivative within 14 days before the beginning of the study (tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs).
- •Participants who have received an anticoagulant (except aspirin ≤150 mg/day) within 7 days before the start of the study.
- •Female participants who are nursing or pregnant, or plan to become pregnant during the study treatment stage of the study.
- •Participants who have been treated with any investigational drug within 30 days of first dose of study treatment.
研究组 & 干预措施
[Step2] CNT201
Experimental
干预措施: [Step2] CNT201 (Drug)
[Step1] CNT201 First-dose
Experimental
干预措施: [Step1] CNT201 First-dose (Drug)
[Step1] CNT201 Low-dose
Experimental
干预措施: [Step1] CNT201 Low-dose (Drug)
[Step1] CNT201 Intermediate-dose
Experimental
干预措施: [Step1] CNT201 Intermediate-dose (Drug)
[Step1] CNT201 High-dose
Experimental
干预措施: [Step1] CNT201 High-dose (Drug)
[Step2] Placebo
Placebo Comparator
干预措施: [Step2] Placebo (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant TumorsNCT07266298Neowise Biotechnology24
招募中
1 期
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)NCT07426419Affinia Therapeutics22
进行中（未招募）
1 期
A Phase I, Dose Escalation, Open-label, Multicenter Study of EA5 Injection in Adults With APS and Recurrent ThrombosisNCT07632976Shanghai Lanyi Therapeutics Co., Ltd.12
尚未招募
2 期
Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell TransplantationNCT07608029Union Hospital, Tongji Medical College, Huazhong University of Science and Technology46
招募中
1 期
Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid TumorsNCT07310134Nanjing Zenshine Pharmaceuticals80