NL-OMON47984已完成不适用
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study to Assess the Safety and Tolerability of JNJ-67670187 in Healthy Participants - 67670187IBD1001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Be a male or female.
- •2. Be 18 (or the legal age of consent in the jurisdiction in which the study is
- •taking place) to 60 years of age, inclusive.
- •3. Have a body mass index (BMI) between 18 and 30 kilogram per square metre
- •(kg/m^2) inclusive, and a body weight of at least 50 kilogram (kg).
- •4. Be otherwise healthy on the basis of physical examination, medical history,
- •and vital signs, and 12-lead electrocardiogram (ECG) performed at screening and
- •at admission.
- •5. Be otherwise healthy on the basis of clinical laboratory tests performed at
- •screening and at admission. If the results of the serum chemistry panel,
- •hematology, or urinalysis are outside the normal reference ranges, the
- •participant may be included only if the investigator judges the abnormalities
- •or deviations from normal to be not clinically significant. This determination
- •must be recorded in the participant's source documents and initialed by the
- •investigator.
排除标准
- •Coexisting Medical Conditions or Past Medical History
- •1. History of any clinically significant medical illness or medical disorders
- •the investigator considers should exclude the participant, including (but not
- •limited to), neuromuscular, hematological disease, immune deficiency state,
- •respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or
- •psychiatric disease, ophthalmological disorders, neoplastic disease, renal or
- •urinary tract diseases, or dermatological disease.
- •2. Has any condition for which, in the opinion of the investigator,
- •participation would not be in the best interest of the participant (eg,
- •compromise the well being) or that could prevent, limit, or confound the
- •protocol-specified assessments.
- •3. Inability to swallow capsules (dysphagia).
- •4. Has a known intolerance or allergy to vancomycin, polyethylene glycol (PEG)
- •laxatives, or any of the excipients in the study interventions.
- •5. Has a known intolerance or allergy to 2 or more classes of the antibiotics
- •that may be used to treat infection with the study intervention (tigecycline,
- •metronidazole, ampicillin/sulbactam, amoxicillin/clavulanate, meropenem,
- •imipenem/cilastatin, and/or vancomycin).
研究者
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