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A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.

2026年11月5日 更新者：Dignify Therapeutics

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) Doses of DTI-117 in Healthy Participants.

This is a single ascending dose, double-blind, placebo-controlled, randomized evaluation of the safety, tolerability, and pharmacokinetics of DTI-117 in healthy volunteers. There will be up to five cohorts of 8 healthy participants each cohort.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

40

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Provide written informed consent to participate.
  • Adult male and female healthy volunteers between 18 to 65 years of age, inclusive.
  • General good health, with no clinically relevant abnormalities as determined by the medical history, physical exam, ECG, and clinical laboratory results.
  • Screening body weight between 45 and 100 kg, inclusive, with body mass index (BMI) ≤32 kg/m2.

Exclusion Criteria:

  • Gastrointestinal or urological surgery in the previous 6 months.
  • Presence of any clinically significant infectious, cardiac, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, in the opinion of the investigator.
  • History of colitis.
  • Current chronic intermittent constipation requiring medication more than twice per month.
  • Use of any investigational drug within 30 days of Screening or 5 drug half-lives, whichever is longer.
  • Individuals not willing or unable to tolerate blood draws or individuals with poor venous access.
  • Presence or history of any condition that, in the opinion of the Investigator, might reasonably jeopardize the safety of the participant, the ability to collect study data, or the validity of the study results.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：0.03 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.03 mg/kg.
药品：DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.
实验性的：0.05 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.05 mg/kg.
药品：DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.
实验性的：0.1 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.1 mg/kg.
药品：DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.
实验性的：0.2 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.2 mg/kg.
药品：DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.
实验性的：0.3 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.3 mg/kg.
药品：DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.
安慰剂比较：Placebo

Participants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP.
药品：Placebo

Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of participants with adverse events
大体时间：Up to seven days

Absolute values and change from baseline
Up to seven days
Number of participants with abnormal lab test results
大体时间：Up to seven days

Absolute values and change from baseline for clinical chemistry and hematology
Up to seven days
Number of participants with abnormal vital signs
大体时间：Up to seven days

Absolute values and change from baseline (oral body temperature, respiratory rate, blood pressure, and heart rate)
Up to seven days
Number of participants with abnormal ECG
大体时间：Up to seven days

Absolute values and change from baseline ECG intervals
Up to seven days

次要结果测量

结果测量
措施说明
大体时间
Pharmacokinetic Cmax
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Maximum (peak) observed concentration of DTI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic Tmax
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Time to maximum observed concentrations of DTI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic half-life (t1/2)
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Time to terminal elimination half-life concentrations of DTI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic AUClast
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Area under the concentration-time curve from zero to the last concentration quantifiable for DTI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic AUCinf
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Area under the plasma concentration-time curve from time zero extrapolated to infinity for TI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic CL/F
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Apparent total plasma clearance after oral administration of TI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic VzF
大体时间：Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

Apparent volume of distribution during terminal elimination phase after oral administration of DTI-117
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Time to urination and defecation
大体时间：24 hours post-dose
24 hours post-dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Dignify Therapeutics

合作者

National Institute of Neurological Disorders and Stroke (NINDS)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月28日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年10月13日

首先提交符合 QC 标准的

2026年10月13日

首次发布 (实际的)

2026年10月20日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • DTI-117-101

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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