A Study to Evaluate the Safety, Tolerability, and Effects on NSAID-Induced Small Bowel Pathology of K-196 in Healthy Volunteers. - CS0394

Kallyope, Inc.0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•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 59 years of age, inclusive, at the Screening Visit.
•4. Have a Body Mass Index (BMI) >=18.0 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 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.

•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)
•prior to 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 (e.g., 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-196,
•related compounds or its excipients.
•5. Has known hypersensitivity to naproxen or any components of the drug product
•6. Has history of asthma, urticaria or other allergic-type reactions after
•taking naproxen or other NSAIDs.

发起方