NL-OMON50582已完成不适用
A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Exploratory Markers of Efficacy for XAB05 in Healthy Subjects. - CS0377 Xenothera
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
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. The subject must understand the nature of the study and must provide signed
- •and dated written informed consent in accordance with local regulations before
- •the conduct of any study-related procedures.
- •2. Healthy as determined by the Investigator, based on a medical evaluation
- •including medical history, physical examination, laboratory tests and ECG
- •recording. A subject with a clinical abnormality or laboratory parameters
- •outside the reference range for the population being studied, may be included
- •only if, in the opinion of the Investigator, the finding is (a) unlikely to
- •introduce additional risk to the subject, (b) will not interfere with study
- •procedures or confound study results, and (c) is not otherwise exclusionary
- •(see Exclusion Criteria).
- •3. The subject is a male or female, aged 18 to 65 years, inclusive, at
- •4. The subject weighs at least 50 kg and has a BMI between 18.0 and 34.0 kg/m2,
- •inclusive, at Screening and on Day -1.
- •5. Women of child-bearing potential must agree not to attempt to become
- •pregnant and to use a highly effective form of hormonal (oral contraception, a
- •hormonal implant, hormonal injection or hormonal intra-uterine devices) or
- •non-hormonal (non-hormonal intra-uterine device/system in combination with a
- •barrier method (e.g. condom, diaphragm, cervical cap with spermicide)) birth
- •control or abstinence during the study and for 90 days after the (last) study
- •drug administration. Postmenopausal women must have had >=12 months of
- •spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) >=30
- •mIU/mL). Surgically sterile women are defined as those who have had a
- •hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are
- •surgically sterile must provide documentation of the procedure by an operative
- •report or by ultrasound. All women must have a negative pregnancy test result
- •at Screening and on Day -1.
排除标准
- •1. The subject has history or evidence of clinically significant hematologic,
- •dermatologic, neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic,
- •gastrointestinal, urologic including difficulty voiding, immunologic, endocrine
- •disease, or psychiatric disorder, or other abnormality, which may impact the
- •ability of the subject to participate or potentially confound the study
- •results, or which, in the investigator*s opinion, makes subjects unsuitable for
- •2. The subject has a significant history of allergies, as determined by the
- •Principal Investigator.
- •3. The subject is taking antihistamines, NSAIDs, or mast cell stabilizers (e.g.
- •disodium cromoglycate) and is unable to stop taking these medications from 7
- •days prior to Day 1.
- •4. The subject has received any prescription or non-prescription drugs
- •(including steroids and COVID-19 vaccination, but excluding paracetamol, oral
- •contraception, a hormonal implant or hormonal intra-uterine devices), vitamins
- •and herbal remedies (including St John*s Wort), within 14 days or 5 half-lives
- •(whichever is longer) prior to Day -1.
- •5. A clinically significant abnormality on physical examination, ECG, or
- •laboratory evaluations at Screening or between Screening and study drug
- •administration.
- •6. The subject has a supine blood pressure outside the ranges of 90 to 140 mm
- •Hg for systolic and 45 to 90 mm Hg for diastolic, confirmed on repeat testing
- •at Screening and on Day -1.
研究者
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