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正在招募I 期编号 NCT07462780

A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants

报名条件(概要)

  • 年龄:18 Years55 Years
  • 性别:不限
  • 健康志愿者:接受

完整入排标准请以官方页面为准。

开展国家/地区

China

研究药物 / 干预措施

CMS-D017 Capsule、CMS-D017 Placebo Capsule、CMS-D017 Capsule、CMS-D017 Placebo Capsule

申办方

Shenzhen Kangzhe Biotechnology Co., Ltd.

研究简介(原文)

This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CMS-D017 capsules following single and multiple oral administrations in healthy Chinese adult participants. Both parts of the study are designed as randomized, double-blind, placebo-controlled, sequential cohort trials. Part 1 SAD plans to include 6 dose cohorts, with 8 participants per cohort (6 receiving CMS-D017 and 2 receiving placebo), for a total of 48 participants. Part 2 MAD plans to include 4 dose cohorts, with 10 participants per cohort (8 receiving CMS-D017 and 2 receiving placebo), for a total of 40 participants.

适应症

Paroxysmal Nocturnal Hemoglobinuria, PNHComplement-mediated Kidney Disease

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

问自己是否符合条件、如何预筛

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
ClinicalTrials.gov Identifier: NCT07462780
Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.
Investigational product: CMS-D017 Capsule, CMS-D017 Placebo Capsule, CMS-D017 Capsule, CMS-D017 Placebo Capsule

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
试验编号:NCT07462780
申办方:Shenzhen Kangzhe Biotechnology Co., Ltd.
研究药物:CMS-D017 Capsule、CMS-D017 Placebo Capsule、CMS-D017 Capsule、CMS-D017 Placebo Capsule

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 chenyulan@cms.net.cn

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面