ISRCTN13328584已完成1 期
A multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of combination K-757 and K-833 in healthy volunteers
Kallyope (United States)0 个研究点目标入组 36 人开始时间: 2024年2月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- 性别
- All
入选标准
- •1. Understand the trial procedures and agree to participate by providing written informed consent
- •2. Be willing and able to comply with all trial procedures and restrictions
- •3. Be healthy between 18 to 55 years of age, inclusive, at the Screening Visit
- •4. Have a Body Mass Index (BMI) =19.0 and <30.0 (kg/m2) at the Screening Visit
- •5. Be a nonsmoker who has not used tobacco or nicotine-containing products (e.g. nicotine patch) for at least 3 months before administration of the initial dose of the trial drug and agrees to abstain from smoking tobacco or the use of nicotine-containing products while on study
- •6. Be judged to be in good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug
- •7. Meet the following birth control requirements:
- •7.1. Is a male subject who agrees to use an appropriate method of contraception, including a condom with or without spermicidal cream or jelly, from the first dose of the study drug until 14 days after the last dose of the study drug. A male subject who had a vasectomy procedure must follow the same restrictions as a non-vasectomized man.
- •7.2. Is a male subject who agrees not to donate sperm from the first dose of the study drug until 14 days after the last dose of the study drug.
- •7.3. Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
- •7.3.1. Postmenopausal (aged >45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone level >30 mIU/mL).
- •7.3.2. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject’s recall of their medical history.
排除标准
- •1. Has participated in another investigational study within the following time period: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer or based on local regulations) before the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study.
- •2. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site
- •3. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food
- •4. Has a known hypersensitivity or contraindication to any component of K-757, K-833, related compounds or its excipients
- •5. Has a positive alcohol or drug screen at Screening or admission
- •6. Has a positive pregnancy test
- •7. Is a lactating/nursing female
- •8. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody, at the Screening Visit. Note: Subjects with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
- •9. Subject does not meet study site COVID-19 admission/study participation restrictions or has a fever (>38oC)
- •10. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the Screening Visit.
- •11. Is unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the first dose of study medication for each dosing period until two days after the last dose of study medication in each Panel, unless in the opinion of the Investigator and Kallyope Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol (=2 grams [g] per day) and COVID vaccination are acceptable.
- •12. Has regular consumption of alcohol within 6 months before screening (>14 drinks/week where l drink= 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of soft drugs (such as marijuana) within 3 months before Screening, or hard drugs (such as cocaine) within 6 months before Screening
- •13. Is unwilling or unable to refrain from study alcohol restrictions: Subjects will refrain from consuming alcohol from 7 days before the first and until the last PK blood sample has been collected and 7 days before the follow-up visit. At all other times, alcohol consumption is limited to no more than approximately 14 drinks/week where 1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor.
- •14. Is unable or unwilling to refrain from consumption of Seville oranges, grapefruit, grapefruit juice, pomelos, exotic citrus fruits, and grapefruit hybrids from 2 weeks before administration of the first dose of study drug, throughout the study, and until the Follow-up Visit
- •15. Unwilling to refrain from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) or charbroiled meats beginning approximately 4
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