NCT05391880已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study of Orally Administered BEBT-503 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- multiple dose safety
研究概览
简要总结
This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects.
The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect of food
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, of any race, between 18 and 55 years of age, inclusive.
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) with a minimum body weight of 50 kg. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, eg, suspicion of Gilbert's syndrome based on total and direct bilirubin, is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee), as applicable.
- •Resting heart rate ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- •Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day-1) until 90 days after the Follow-up visit.
- •Participants have ability to swallow and retain oral medication.
- •Able to comprehend and willing to sign an Information and Consent Form and to abide by the study restrictions.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy).
- •History of malignancy (cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ are eligible).
- •Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
- •Any of the following:
- •corrected QT interval by Fridericia formula> 450 msec confirmed by repeat measurement.
- •QRS duration > 120 msec confirmed by repeat measurement.
- •PR interval > 220 msec confirmed by repeat measurement.
- •findings which would make corrected QT interval measurements difficult or corrected QT interval data uninterpretable.
- •history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- •History of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
- •Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- •Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.
- •Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.
- •Participation in a clinical study involving administration of an investigational agent or vaccine (new chemical entity) or having received a biological product in the past 90 days prior to dosing.
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- •Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- •Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- •Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- •Use of tobacco- or nicotine-containing products within 1 month prior to Check-in, or positive cotinine at Screening or Check-in.
- •Receipt of blood products within 2 months prior to Check-in and donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- •Any major surgery within 4 weeks prior to first dosing.
- •Poor peripheral venous access.
- •Have previously completed or withdrawn from this study investigating BEBT-503, and have previously received the investigational product.
- •Subject who, in the opinion of the Investigator (or designee), should not participate in this study.
- •Subject is not willing to minimize or avoid exposure to natural or artificial sunlight (tanning beds or ultraviolet A/B treatment) following administration of study drug until 24 hours after the last dose.
研究组 & 干预措施
Drug:BEBT-503
Experimental
BEBT-503
干预措施: BEBT-503 40mg (Drug)
Drug:BEBT-503
Experimental
BEBT-503
干预措施: BEBT-503 80mg (Drug)
Drug:BEBT-503
Experimental
BEBT-503
干预措施: BEBT-503 120mg (Drug)
Drug:BEBT-503
Experimental
BEBT-503
干预措施: BEBT-503 180mg (Drug)
Drug:BEBT-503
Experimental
BEBT-503
干预措施: BEBT-503 20mg (Drug)
Drug: Placebo
Placebo Comparator
Placebo
干预措施: placebo 20mg (Drug)
Drug: Placebo
Placebo Comparator
Placebo
干预措施: placebo 40mg (Drug)
Drug: Placebo
Placebo Comparator
Placebo
干预措施: placebo 80mg (Drug)
Drug: Placebo
Placebo Comparator
Placebo
干预措施: placebo 120mg (Drug)
Drug: Placebo
Placebo Comparator
Placebo
干预措施: placebo 180mg (Drug)
结局指标
主要结局
multiple dose safety
时间窗: from baseline to Day18
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
single dose safety
时间窗: from baseline to Day10
Number of the Adverse Events that are related to the single dose treatment from baseline to Day 10
次要结局
- Vz/F after single dose(Pre-dose to 48 hours postdose)
- AUC0-∞ after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- AUC0-∞ after single dose(Pre-dose to 48 hours postdose)
- t1/2 after single dose(Pre-dose to 48 hours postdose)
- Cmax after single dose(Pre-dose to 48 hours postdose)
- Tmax after single dose(Pre-dose to 48 hours postdose)
- CL/F after single dose(Pre-dose to 48 hours postdose)
- AUC0-τ after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- Cmax after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- t1/2 after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- Tmax after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- Cmin after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- RAAUC0-τ after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- RACmax after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
- effect of food on the single oral dose AUC0-∞(Pre-dose to 48 hours postdose)
- effect of food on the single oral dose Cmax(Pre-dose to 48 hours postdose)
- effect of food on the single oral dose Tmax(Pre-dose to 48 hours postdose)
- effect of food on the single oral dose t1/2(Pre-dose to 48 hours postdose)
- effect of food on the single oral dose CL/F(Pre-dose to 48 hours postdose)
- effect of food on the single oral dose Vz/F(Pre-dose to 48 hours postdose)
- metabolites of BEBT-503 in urine(Pre-dose to 48 hours postdose)
- metabolites of BEBT-503 in plasma(Pre-dose to 48 hours postdose)
研究者
研究点 (1)
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