A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
报名条件（概要）
- 年龄：18 Years – 45 Years
- 性别：男性
- 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
药品与企业信息
Ascending single doses - 4 dose levels
Ascending single doses - 4 dose levels
single subcutaneous injection
single subcutaneous injection
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec and insulin icodec injection serves as the active control and is administered in an open-label manner. The study will be conducted across 6 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) ， 1 active control cohort of insulin degludec (0.4 U/kg \[2.4 nmol/kg\]) and 1 active control cohort of insulin icodec (1.25 U/kg \[7.5 nmol/kg\]). The safety and tolerability (including local tolerability) as well as the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single subcutaneous doses of UBT38006 injection will be evaluated in healthy adult male participants. In Cohort 1 (1 nmol/kg), participants will be randomized in a 4:1 ratio to receive UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol/kg), participants will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Participants in Cohort 5 (insulin degludec active control) will receive 0.4 U/kg (2.4 nmol/kg) insulin degludec injection. Participants in the insulin icodec cohort received a subcutaneous injection of insulin icodec at a dose of 1.25 U/kg(7.5 nmol/kg). Cohorts 1-4 will follow a double-blind design, while Cohort 5 and insulin icodec cohort will be open-label.
适应症
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
- The Second Hospital of Anhui Medical UniversityHefei，Anhui，China
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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 Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males ClinicalTrials.gov Identifier: NCT07630233 Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. Investigational product: UBT38006, Placebo, Insulin Degludec Injection, Insulin Icodec Injection 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 Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males 试验编号：NCT07630233 申办方：The United Bio-Technology (Hengqin) Co., Ltd. 研究药物：UBT38006、Placebo、Insulin Degludec Injection、Insulin Icodec Injection 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）
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下一步怎么做？
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- 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）。