Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.
Summary
BK virus (BKV) is a member of the polyomavirus family with a prevalence of up to 90% in the general population. In immunocompromized individuals, such as kidney transplant recipients (KTRs) who receive immunosuppressant therapy to prevent graft rejection, BKV turns into an opportunistic pathogen. BK viremia has been reported to occur in 10-30% of KTRs. BKV is recognized as a leading cause of impaired graft function and premature transplant loss, and is therefore a serious condition in kidney transplant patients. At present, there are no effective agents specifically against BKV available and thus no standard treatment that can effectively reduce or prevent BKV infection/reactivation after renal transplantation. Therefore, the proposed indication for the AntiBKV neutralizing antibody is the treatment of BK virus infections and prevention of BK virus associated complications in KTRs. This study has been designed to evaluate the safety, tolerability, and pharmacokinetic of ascending doses of AntiBKV, a fully human highly neutralising antibody against BKV, administered as a single or multiple intravenous infusions to healthy adult participants. The data obtained in this study will provide the basis for further clinical development of AntiBKV.
Timeline
- Start
- 2022-05-09
- Primary completion
- 2022-12-05
- Completion
- 2023-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | potravitug | Protein / enzyme biologic | 100 mg | Intravenous |
| Comparator | potravitug | Protein / enzyme biologic | 500 mg | Intravenous |
| Comparator | potravitug | Protein / enzyme biologic | 1000 mg | Intravenous |
| Comparator | potravitug | Protein / enzyme biologic | 2000 mg | Intravenous |