Pharmacokinetics, Safety, and Tolerability of SYN-020
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
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Wisconsin
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West Bend、Wisconsin、美国、53095
- Spaulding Clinical Research LLC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
- Subject is a healthy male or female, aged 18 through 50 years, inclusive.
- 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.
- 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.
- Subject is healthy based on physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.
- 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.
- If female, subject has a negative serum pregnancy test at Screening and on Day -1 (CRU admission).
- Subject usually has at least 1 bowel movement a day based on self-reporting.
Exclusion Criteria:
- 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.
- Subject has any known malabsorption syndrome or history of gastrointestinal surgery that could compromise the study objectives.
- 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.
- Subject is pregnant, breastfeeding, or not using a medically accepted method of contraception.
- 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.
- 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.
- Subject has donated more than 500 mL blood during the 3-month period before Day -1.
- Subject has known intolerance of study drug/ingredients.
- In the judgment of the Investigator, subject has any factor (eg, other treatment) that could invalidate the study result.
- 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.
- Subject has already participated in this study.
学习计划
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 |
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实验性的:SYN-020, 5 mg
6 subjects to receive a single 5 mg dose of SYN-020
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SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
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实验性的:SYN-020, 15 mg
6 subjects to receive a single 15 mg dose of SYN-020
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SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
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实验性的:SYN-020, 45 mg
6 subjects to receive a single 45 mg dose of SYN-020
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SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
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实验性的:SYN-020, 150 mg
6 subjects to receive a single 150 mg dose of SYN-020
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SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
其他名称:
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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 |
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SYN-020 systemic absorption
大体时间:Daily Day 1 through Day 5
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Analysis of SYN-020 level present in blood
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Daily Day 1 through Day 5
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SYN-020 presence in feces
大体时间:Daily Day -1 through Day 6
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Analysis of SYN-020 level present in feces
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Daily Day -1 through Day 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants with Changes in Clinical Laboratory Testing
大体时间:Day -1, Day 2, Day 6
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Hematology, clinical chemistry, urinalysis, virus serology, drug screen, alcohol screen, pregnancy test, postmenopausal screen
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Day -1, Day 2, Day 6
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Number of Participants With Changes in Physical exam
大体时间:Day 1 and Day 6
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Complete and abbreviated physical examinations will be performed
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Day 1 and Day 6
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Number of Participants with Changes in Vital Signs
大体时间:Daily Day -1 through Day 6
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Blood pressure, pulse rate, respiratory rate, oral temperature
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Daily Day -1 through Day 6
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Number of Participants with Changes in Electrocardiograms
大体时间:Day -1, Day 1, Day 2, Day 6
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12-lead ECG, P-wave, QRS-complex, QT-interval
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Day -1, Day 1, Day 2, Day 6
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Immunogenicity testing
大体时间:Day 1, Day 6
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Measurement of anti-drug antibodies by ELISA
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Day 1, Day 6
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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SYN-020 delayed release capsule的临床试验
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Synthetic Biologics Inc.Spaulding Clinical Research LLC完全的