A phase 1 single ascending dose study in healthy subjects to evaluate safety, tolerability, and pharmacokinetics of XVR011
- Conditions
- COVID-1910047438
- Registration Number
- NL-OMON49939
- Lead Sponsor
- ExeVir Bio BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
allergies.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of XVR011 after an intravenous (iv)<br /><br>infusion of single ascending doses in healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the pharmacokinetic (PK) profile of XVR001 after an iv infusion of<br /><br>single ascending doses in healthy subjects<br /><br>(Exploratory: To evaluate the immunogenicity of XVR011 after an iv infusion of<br /><br>single ascending doses in healthy subjects.)</p><br>