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Pharmacokinetics, Safety, and Tolerability of SYN-020

2021年10月7日 更新者:Synthetic Biologics Inc.

A Single Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN-020 Delayed Release Capsules in Healthy Subjects

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile.

For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.

研究概览

详细说明

Intestinal alkaline phosphatase (IAP) is a naturally occurring enzyme produced by the small intestine in all mammals, including humans, and is considered essential for promoting normal gastrointestinal (GI) function and maintaining proper gut homeostasis, as well as appearing to play a pivotal role in the mediation of inflammation.

SYN-020 is a recombinant bovine IAP isotype II being developed by Synthetic Biologics, Inc. to reduce the cumulative GI toxicity and inflammation that can be associated with repeat administration of radiation in patients with cancer.

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, with 6 subjects (approximately equal numbers of male and females) in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile, and will be described fully in a protocol amendment.

For each cohort, eligible subjects will be admitted to the clinical research unit (CRU) on Day -1, and subjects who remain eligible will, after a minimum 10-hour overnight fast, receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the CRU after the End of Study (EOS) procedures are completed on Day 6.

研究类型

介入性

注册 (实际的)

24

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。

学习地点

    • Wisconsin
      • West Bend、Wisconsin、美国、53095
        • Spaulding Clinical Research LLC

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 50年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subject is able to read, write, and comprehend English at a sufficient level to understand study related materials, has provided written informed consent before any study-related procedure was performed, and is willing and able to comply with all testing and study requirements.
  2. Subject is a healthy male or female, aged 18 through 50 years, inclusive.
  3. Subject does not use any tobacco or nicotine product (eg, cigarette, pipe, e-cigarette, vape) and has not used any tobacco or nicotine product for at least 2 months before Day -1.
  4. Subject has a BMI of 18.5 to 27 kg/m2 for initial cohorts or, for exploratory cohorts, ≥ 27.1 kg/m2. For Cohorts 1 through 4, if insufficient subjects are available to meet this criterion, subjects with a BMI up to 29 kg/m2 may be included with written authorization from the Sponsor.
  5. Subject is healthy based on physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.
  6. Subject is willing to minimize the risk of inducing pregnancy from the time of signing the informed consent form (ICF) to at least either 90 days (males) or 30 days (females) after the study drug dose.
  7. If female, subject has a negative serum pregnancy test at Screening and on Day -1 (CRU admission).
  8. Subject usually has at least 1 bowel movement a day based on self-reporting.

Exclusion Criteria:

  1. Subject has a history or the presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, vascular, metabolic, collagen, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
  2. Subject has any known malabsorption syndrome or history of gastrointestinal surgery that could compromise the study objectives.
  3. Subject has used any medication (prescription or non-prescription) or herbal supplement, other than prescription hormone replacement therapy (eg, thyroid, testosterone, estrogen) or contraception methods described in Inclusion Criterion #6, within 21 days before Day -1.
  4. Subject is pregnant, breastfeeding, or not using a medically accepted method of contraception.
  5. Subject is unable to abstain from artificial sweeteners (eg, aspartame, acesulfame potassium, advantame, saccharin, stevia, and sucralose) from CRU admission to the end of study participation.
  6. Subject has a positive urine drug or alcohol test at Screening or CRU admission OR has a history of drug/alcohol abuse within 12 months before Screening.
  7. Subject has donated more than 500 mL blood during the 3-month period before Day -1.
  8. Subject has known intolerance of study drug/ingredients.
  9. In the judgment of the Investigator, subject has any factor (eg, other treatment) that could invalidate the study result.
  10. Subject is currently enrolled in another clinical study or has received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the ICF, whichever is longer.
  11. Subject has already participated in this study.

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:非随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:SYN-020, 5 mg
6 subjects to receive a single 5 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
  • Intestinal Alkaline Phosphatase
实验性的:SYN-020, 15 mg
6 subjects to receive a single 15 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
  • Intestinal Alkaline Phosphatase
实验性的:SYN-020, 45 mg
6 subjects to receive a single 45 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
  • Intestinal Alkaline Phosphatase
实验性的:SYN-020, 150 mg
6 subjects to receive a single 150 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
  • Intestinal Alkaline Phosphatase

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
SYN-020 systemic absorption
大体时间:Daily Day 1 through Day 5
Analysis of SYN-020 level present in blood
Daily Day 1 through Day 5
SYN-020 presence in feces
大体时间:Daily Day -1 through Day 6
Analysis of SYN-020 level present in feces
Daily Day -1 through Day 6

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants with Changes in Clinical Laboratory Testing
大体时间:Day -1, Day 2, Day 6
Hematology, clinical chemistry, urinalysis, virus serology, drug screen, alcohol screen, pregnancy test, postmenopausal screen
Day -1, Day 2, Day 6
Number of Participants With Changes in Physical exam
大体时间:Day 1 and Day 6
Complete and abbreviated physical examinations will be performed
Day 1 and Day 6
Number of Participants with Changes in Vital Signs
大体时间:Daily Day -1 through Day 6
Blood pressure, pulse rate, respiratory rate, oral temperature
Daily Day -1 through Day 6
Number of Participants with Changes in Electrocardiograms
大体时间:Day -1, Day 1, Day 2, Day 6
12-lead ECG, P-wave, QRS-complex, QT-interval
Day -1, Day 1, Day 2, Day 6
Immunogenicity testing
大体时间:Day 1, Day 6
Measurement of anti-drug antibodies by ELISA
Day 1, Day 6

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。

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)

2021年3月22日

初级完成 (实际的)

2021年5月18日

研究完成 (实际的)

2021年9月30日

研究注册日期

首次提交

2021年3月12日

首先提交符合 QC 标准的

2021年3月22日

首次发布 (实际的)

2021年3月25日

研究记录更新

最后更新发布 (实际的)

2021年10月15日

上次提交的符合 QC 标准的更新

2021年10月7日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • SB-1-020-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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

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.

SYN-020 delayed release capsule的临床试验

3
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