NCT05358106: SAFE KIDNEY I

Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.

Completed Phase 1 Last updated 18 June 2023

What this trial tests

Phase 1 trial testing AntiBKV in BK Virus Nephropathy in 40 participants. Completed in 2 April 2023.

Timeline

9 May 2022

Primary endpoint
5 December 2022

2 April 2023

Quick facts

Lead sponsor	Memo Therapeutics AG
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	9 May 2022
Primary completion	5 December 2022
Estimated completion	2 April 2023
Sites	1 location across Australia

Drugs / interventions tested

• AntiBKV — full drug profile →
• Placebo

Conditions studied

• BK Virus Nephropathy — all drugs for BK Virus Nephropathy →

Sponsor

Memo Therapeutics AG — full company profile →

Who can join

Adults 18 to 50, any sex, with BK Virus Nephropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients.
   Helle F, Aubry A, Morel V, Descamps V, et al · · 2024 · cited 15× · PMID 39352862 · DOI 10.1681/asn.0000000000000457
2. A multivalent polyomavirus vaccine elicits durable neutralizing antibody responses in macaques.
   Peretti A, Scorpio DG, Kong WP, Pang YS, et al · · 2023 · cited 12× · PMID 36764908 · DOI 10.1016/j.vaccine.2023.02.002
3. A cluster of broadly neutralizing IgG against BK polyomavirus in a repertoire dominated by IgM.
   Nguyen NK, Devilder MC, Gautreau-Rolland L, Fourgeux C, et al · · 2023 · cited 7× · PMID 36717250 · DOI 10.26508/lsa.202201567
4. First-In-Human, Randomized, Placebo-Controlled, SAD and MAD Trial to Evaluate Safety, Tolerability, and PK/PD Modeling of Potravitug in Healthy Adults.
   May M, Bialek-Waldmann JK, Wright A, Gruver S, et al · · 2025 · cited 1× · PMID 40788782 · DOI 10.1111/cts.70316