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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Clinical safety and laboratory parameters-Vital Signs, pulse
研究概览
简要总结
This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects. All participants will receive G3P-01 in sequential, escalating doses of 50mg (Period 1), 500mg (Period 2), 1,000mg (Period 3), and 2,000mg (Period 4). A wash out period of at least 7 days will occur between doses in each sequential treatment period. Subjects will be admitted Day 1 and stay overnight until the morning of Day 2 for each treatment period. There will be a follow up call 14 days (+/- 2 days) following the last dose of the IP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged ≥ 18 to < 65 years;
- •Healthy volunteers, as determined by a comprehensive clinical assessment performed at screening (medical history, vital signs, clinical laboratory testing, ECG, and general physical examination);
- •Maintains a regular (mixed or vegetarian/vegan) diet.
- •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;
- •Willing to adhere to the prohibitions and restrictions specified in the protocol;
- •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
- •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;
- •Clinically significant abnormal laboratory test values at screening, as determined by the Investigator;
- •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.
- •Any positive urine drug screen or alcohol test at Screening or clinic admission.
- •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.
- •History of alcohol abuse within 6 months prior to Screening and/or signs or symptoms of alcoholism, as determined by the Investigator.
- •Positive test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV);
- •Participation in another clinical trial of an investigational drug (or medical device), or food supplement within 30 days prior to screening, or currently participating in another trial of an investigational drug (or medical device), or food supplement;
- •Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to investigational product administration.
- •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.
- •Traveled via airplane or cruise ship within the last 14 days
结局指标
主要结局
Clinical safety and laboratory parameters-Vital Signs, pulse
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in vital signs reported as AEs. Measured by pulse.
Clinical safety and laboratory parameters-Clinical Laboratory Results,hematology
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Hematology/Serum Chemistry.
Clinical safety and laboratory parameters-Vital Signs, respiratory rate.
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in vital signs reported as AEs. Measured by respiratory rate.
Clinical safety and laboratory parameters-Vital Signs, body temperature.
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in vital signs reported as AEs. Measured by body temperature.
Number, severity, and nature of adverse events following the administration of ascending doses of G3-P01
时间窗: Through study completion, up to 70 days
Evaluating the safety of ascending doses of G3-P01 based on treatment related adverse events
Clinical safety and laboratory parameters-Clinical Laboratory Results, urinalysis
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Urinalysis.
Clinical safety and laboratory parameters- Adverse Events
时间窗: Through study completion, up to 70 days
Number of participants with treatment emergent adverse events. Measured by observation and reporting
Clinical safety and laboratory parameters-Clinical Laboratory Results, serology
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Serology,
Clinical safety and laboratory parameters-Vital Signs, blood pressure
时间窗: Through study completion, up to 70 days
Number of participants with clinically significant change in vital signs reported as AEs. Measured by BP
Change from baseline in tolerability assessment using Questionnaire
时间窗: Through study completion, up to 70 days
Tolerability assessment using the Gastrointestinal Symptom Rating Scale (GSRS). There are 15 individual questions, each with a score of 1-7. Higher scores reflect a worse outcome.
Change from baseline in performance status using Questionnaire
时间窗: Through study completion, up to 70 days
Performance status assessment using the Karnofsky Performance Scale Index. The scale is 0-100, with 0 reflecting a worse outcome.
次要结局
- Pharmacokinetic parameters- dose proportionality(Up to 3 years)
- Pharmacokinetic parameters- Cmax(Up to 3 years)
- Pharmacokinetic parameters- Vd(Up to 3 years)
- Pharmacokinetic parameters- Tmax(Up to 3 years)
- Pharmacokinetic parameters- Clr(Up to 3 years)
- Pharmacokinetic parameters- AUC(Up to 3 years)
- Pharmacokinetic parameters- T1/2/ el(Up to 3 years)