Healthy volunteers Other
Conditions
Interventions
All subjects received an intravenous dose of 0.25 mg/kg imlifidase on Day 1, administered over 15 minutes. Follow up for 14 days.
Sponsors
Hansa Biopharma (Sweden)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy man 2. Between 20 and 60 years old 3. Both parents and all 4 grandparents were ethnically Japanese
Exclusion criteria
Exclusion criteria: 1. Previous participation in this study 2. Present participation in another clinical trial, or use of any investigational drug or therapy, taking into account participation in a medical device study, within 90 days or 5 half-lives, whichever is longer, prior to administration of IMP 3. Prescence or history of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK was measured as concentration of imlifidase in serum from pre-dose until Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety was assessed as adverse events (AEs) from obtaining the informed consent throughout the study. An AE is any untoward medical occurrence in a subject participating in the clinical trial. An AE could be any unfavourable and unintended sign, symptom or disease temporally associated with the treatment, whether or not considered related to the study drug 2. PD was assessed as concentration of IgG in serum throughout the study | — |
Countries
England, United Kingdom
Contacts
Public ContactDavid Steel
Outcome results
None listed