NL-OMON51278已完成不适用
A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers - G3P-01-01
G3P, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female, aged * 18 to < 65 years;
- •2. Healthy volunteers, as determined by a comprehensive clinical assessment
- •performed at screening (medical history, vital signs, clinical laboratory
- •testing, ECG, and general physical examination);
- •3. Maintains a regular (mixed or vegetarian/vegan) diet.
- •4. Non-pregnant, non-lactating females who are either post-menopausal (natural
- •or surgical) or are using at least one (1) of the following forms of
- •contraception:
- •* Intrauterine device (IUD),
- •* Implantable progestogen-only hormone contraception associated with inhibition
- •of ovulation,
- •* Intrauterine hormone-releasing system (IUS),
- •* Bilateral tubal occlusion
- •* Vasectomized partner
- •* Male or female condom with or without spermicide,
- •* Cervical cap, diaphragm, or sponge with spermicide,
- •* A combination of male condoms with either cervical cap, diaphragm, or sponge
- •with spermicide (double-barrier methods)
- •* Combined (estrogen- and progestogen-containing) hormonal contraception
- •associated with inhibition of ovulation
- •- intravaginal
- •- transdermal
- •- injectable
- •* Progestogen-only hormone contraception associated with inhibition of ovulation
- •- injectable
- •* Abstinence;
- •5. Willing to adhere to the prohibitions and restrictions specified in the
- •6. Must be competent to understand the nature of the study and capable of
- •giving written informed consent and be willing to report for the scheduled
- •study visits and communicate to study personnel about adverse events and
- •concomitant medication use.
排除标准
- •1. History of any clinically significant cardiac, endocrine, gastrointestinal,
- •hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,
- •dermatologic, psychiatric, or renal disease, or other major disease, as
- •determined by the Investigator;
- •2. Clinically significant abnormal laboratory test values at screening, as
- •determined by the Investigator;
- •3. Any surgical or medical condition, which in the opinion of the Investigator
- •may pose an undue risk to the subject, interfere with participation in the
- •study, or which may affect the integrity of the study data.
- •4. Any positive urine drug screen or alcohol test at Screening or clinic
- •5. Concomitant use of any drugs known to interact with oral absorption or
- •metabolism of pharmaceuticals, including known inducers or inhibitors of
- •cytochrome p450 enzyme system.
- •6. History of alcohol abuse within 6 months prior to Screening and/or signs or
- •symptoms of alcoholism, as determined by the Investigator.
- •7. Positive test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human
- •Immunodeficiency Virus (HIV);
- •8. Participation in another clinical trial of an investigational drug (or
- •medical device), or investigational food supplement within 30 days prior to
- •screening, or currently participating in another trial of an investigational
- •drug (or medical device), or food supplement;
- •9. Donation of greater than 100 mL of either whole blood or plasma within 30
- •days prior to investigational product administration.
- •10. Been informed of possible COVID-19 exposure in past 4 weeks, or recent
- •onset of signs or symptoms of possible COVID-19 infection, including cough,
- •shortness of breath, or temperature * 38°C.
- •11. Traveled via airplane or cruise ship within the last 14 days
研究者
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