COVID-19
Conditions
Interventions
In the table below are the planned treatments for this study. The doses of
Groups 2 and 3 may be adjusted. For example because XVR011 had more or less
effect than was expected. However, the dose wil
Sponsors
ExeVir Bio BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of XVR011 after an intravenous (iv) infusion of single ascending doses in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic (PK) profile of XVR001 after an iv infusion of single ascending doses in healthy subjects (Exploratory: To evaluate the immunogenicity of XVR011 after an iv infusion of single ascending doses in healthy subjects.) | — |
Countries
Netherlands
Outcome results
None listed