A phase 1 single ascending dose study in healthy subjects to evaluate safety, tolerability, and pharmacokinetics of XVR011 - Single ascending dose (SAD) study with XVR011 in healthy subjects

ExeVir Bio BV0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Sex: male or female; females may be of childbearing potential or of
•nonchildbearing potential (ie, surgically sterilized, physiologically incapable
•of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of
•12 consecutive months and confirmed by a serum follicle stimulating hormone
•(FSH) test at screening]).
•2. Age: 18 to 65 years, inclusive, at screening.
•3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
•4. Weight : >=50 kg.
•5. In good physical and mental health on the basis of medical history, physical
•examination, clinical laboratory, ECG, and vital signs, as judged by the
•Investigator.
•6. Subject is fully vaccinated against COVID-19 at least 14 days prior to study
•drug administration, or has had COVID-19 previously and is willing to delay any
•potential further planned vaccination until 90 days after study drug
•administration, or is not planning any vaccination until 90 days after study
•drug administration for reasons other than participation in this study.
•Previous COVID infection must not have been within 2 months prior to the date
•of screening.

•1. Previous participation in the current study.
•2. Employee of PRA or the Sponsor.
•3. History of relevant drug allergies (eg, allergy or hypersensitivity reaction
•to any monoclonal antibody or to any components of the study drug) and/or food
•4. Using tobacco products within 60 days prior to study drug administration.
•5. History of alcohol abuse or drug addiction within 12 months prior to the
•screening visit (including soft drugs like cannabis products).
•6. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
•[including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma
•hydroxybutyric acid, tricyclic antidepressants, and alcohol) at screening or
•admission to the clinical research center.

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