A Phase I, Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral YUQ-A1007 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- The safety and tolerability of YUQ-A1007 administered orally
研究概览
简要总结
YUQ-A1007 is a novel gut-enriched AhR agonist. The nonclinical pharmacology study indicated that YUQ-A1007 has the potential to treat IBD.
YUQ-A1007 has not been evaluated in human clinical studies. This study is first-in-human (FIH) study of YUQ-A1007. The goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics of oral YUQ-A1007.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Written informed consent prior to the conduct of any study-related assessments.
- •Aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
- •Male and Female participants.
- •Has body mass index (BMI) as 18.5-27.9 kg/m2 with total body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants at screening.
- •With normal liver and kidney functions.
- •With normal results of clinical laboratory tests or abnormal results of clinical laboratory tests deemed not clinically significant as per investigator judgement at screening and on admission to the CRU.
- •Willing and able to comply with the study requirements, including remaining at the CRU for the in-house portion of study participation.
- •Agrees not to smoke, vape, or consume tobacco or other nicotine-containing products, not to consume alcohol, not to consume beverages containing caffeine or other xanthines.
- •Is in good health based on the medical history, physical examination, vital signs measurements, laboratory tests, and 12-lead ECGs performed at screening.
排除标准
- •Any condition that places the participant at significantly increased risk or may compromise the study objectives.
- •Is mentally or legally incapacitated at screening.
- •History of malignant neoplasms or carcinoma in situ.
- •Has a current or chronic history of liver disease or known hepatic or biliary abnormalities.
- •Has had symptomatic herpes zoster.
- •Has a history of any known relevant allergy/hypersensitivity or intolerance.
- •Has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- •Has a sensitivity to heparin or history of heparin-induced thrombocytopenia.
- •Has a clinically significant infection.
- •Any history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological.
- •Has a clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study.
- •Any clinically significant abnormality identified in the physical examination (including vital signs) or electrocardiographic testing.
- •Has a positive test for the presence of human immunodeficiency virus (HIV), hepatitis C antibody, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of investigational product.
- •Has active or latent tuberculosis (TB), regardless of treatment history, or positive diagnostic TB test at screening.
- •Has received treatment with a live, attenuated vaccine within 4 weeks prior to the first dose of investigational product or anticipation of need for such a vaccine during study participation.
- •Has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
- •Has donated or lost blood or blood products in volumes of 450 mL or more within 30 days.
- •Has had prior exposure to YUQ-A
- •Has participated in a study of any investigational drug, device, biologic, or other agent within 30 days or 5 half-lives prior to screening, whichever is longer.
- •Has received any prescription medications, over-the-counter medications, herbal supplements, or vitamins within 30 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
- •Is an employee or has a family member who is an employee of the CRU and is involved in the conduct of the study and/or supervised by the investigator; or is an employee or has a family member who is an employee of the sponsor.
研究组 & 干预措施
SAD
Single Ascending Dose Stage in Healthy Volunteers， 4 cohorts will be included
干预措施: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies. (Drug)
MAD
Multiple Ascending Dose Stage in Healthy Volunteers, two dose levels will be included
干预措施: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies. (Drug)
结局指标
主要结局
The safety and tolerability of YUQ-A1007 administered orally
时间窗: during the intervention (about 6 months)
Number of participants with Treatment-emergent adverse events (TEAEs), with clinically significant changes from baseline in vital signs (body temperature, blood pressure, heart rate, and respiratory rate), physical examination findings, and 12-lead electrocardiogram (ECG) parameters, and with clinically significant changes from baseline in safety laboratory assessments (hematology, clinical chemistry, urinalysis, and stool routine test)
次要结局
未报告次要终点