BK Virus NephropathyPhase 1SAFE KIDNEY INCT05358106

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

A Phase 1 study testing AntiBKV in people with BK Virus Nephropathy, run by Memo Therapeutics AG at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: BK Virus Nephropathy
What is being tested?: AntiBKV
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteAustralia
Study dates: 9 May 2022to 2 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female participants aged 18 years to 50 years at the time of consent
Ability to read, understand and provide written informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including lifestyle restrictions for the duration of the study
Healthy participants as established by medical history, laboratory examination, physical examination, vital signs, and ECG during screening and as per the clinical judgment of the investigator
Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive)
For Woman of Childbearing Potential (WOCBP): agrees to practice true abstinence or agrees to use a highly effective method of contraception consistently from 30 days prior to Day 1 until at least 30 days post-dose. Highly effective contraception includes hormonal contraception, placement of intrauterine device (IUD) or intrauterine system (IUS), or a vasectomized partner (performed at least 6 months prior to her screening) who has been documented to no longer produce sperm. Verbal confirmation from the participant through medical interview is acceptable. No contraception requirements for participants in exclusive same-sex relationship.
For male participant: must agree to practice true abstinence or use condom if he has a partner of childbearing potential or must be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm. Verbal confirmation through medical interview is acceptable). Participant to practice abstinence (if applicable) or use condom for at least 30 days post-dose. No contraception requirements for participants in exclusive same-sex relationship.
Accessible veins in the forearms for venepuncture and/or intravenous cannulation

Who cannot join

Participant with active SARS-CoV-2 infection
Participants tested positive for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)
History of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation.
History of any reaction to monoclonal antibodies.
History of allergic disease or reactions likely to be exacerbated by any component of the study drug, as assessed by the investigator, and/or known allergies to the trial product or its components.
History of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or clinically significant mental disability that may interfere with the participant's ability to provide informed consent, as per discretion of the investigator. Gilbert's syndrome and history of cholecystectomy or cholecystitis will not be considered exclusionary.

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Any abnormal laboratory finding at screening and at Day -1 (one retest is allowed at screening and/or at Day -1) unless deemed not clinically significant and irrelevant for study participation by the discretion of the investigator. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 × upper limit of normal and/or glomerular filtration rate (GFR) <60ml/min are always considered exclusionary.
Acute illness (moderate or severe) and/or fever (body temperature ≥ 38 °C) during the 72 hours prior to any planned study drug application.
Participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder. Participants with seasonal allergies and mild asthma may be included.
Receipt of immunoglobulin or blood products within 6 months prior to enrolment.
Receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer.
Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study.
Receipt, or planned receipt of any standard vaccine within 7 days prior to and 7 days post Day 1 or planned vaccination within 7 days prior to and post any subsequent dosings.
History of alcoholism (>10 drinks/week) or drug addiction within 1 year prior to screening.
Positive screen for drugs of abuse or alcohol (breath test) at screening or Day -1 and prior to any subsequent dosings. A test may be repeated once at the discretion of the investigator to confirm suspected false-positive results.
Use of prescription drugs within 7 days prior to Day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives.
Use of over-the-counter medication within 7 days prior to Day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor.
Receipt of immunosuppressive medications within 6 months prior to enrolment (receipt of any course of systemic corticosteroids for more than a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed).
Pregnant, lactating, or planned pregnancy during the study period.
Inability to comply with the study protocol in the opinion of the investigator.
Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
Concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study.
Participant has clinically significant 12-lead ECG abnormalities at screening.
Abnormal vital signs including systolic blood pressure (SBP) < 90 or > 160 mmHg, diastolic blood pressure (DBP) < 50 or > 95 mmHg, heart rate (HR) < 45 or > 100 bpm (average of triplicate measurements) at screening.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 1, Single-blind, Partially Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Intravenous Doses of AntiBKV in Healthy Adult Volunteers.

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.

Read the detailed description

BK virus (BKV) is a member of the polyomavirus family with a prevalence of up to 90% in the general population. It lies dormant and rarely causes disease in healthy individuals. However, in immunocompromized individuals, such as kidney transplant recipients (KTRs) who receive immunosuppressant therapy to prevent graft rejection, BKV turns into an opportunistic pathogen.

BKV replication can be detected before the development of BK virus associated nephropathy (BKVAN) and first virus shedding is detected in the urine. BK viremia has been reported to occur in 10-30% of KTRs. BKVAN progression is detected by a median of 8 weeks after establishment of the persistent viremia, and occurs most commonly in the first 2 years post-transplantation or following treatment of graft rejection. BKV infection/reactivation in these patients can lead to progression to BKVAN in up to 10% of all KTRs, while ultimately leading to graft dysfunction in 38% of patients and loss in 20% of patients presenting with BK viremia. 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.

The current standard of care after kidney transplantation involves prospective screening for BKV reactivation post-transplantation and subsequent reduction of immunosuppression to strengthen immune responses against BKV. Although reduction of immune suppression is a widely accepted management option, approaches for dose tapering differ with no consensus existing regarding when and which agent should be reduced or stopped following a diagnosis of BKV infection.

The proposed indication for the AntiBKV neutralizing antibody is the treatment of BK virus infections and prevention of BK virus associated complications in KTRs. In KTRs, the detection of the BK virus in the blood has been found to be strongly associated with the development of BKVAN and the grade of BK viremia correlates with the onset of the renal disease. A decrease of the virus load significantly reduces the chance for progression to BKVAN. Treatment of BK viremia with AntiBKV in KTRs with BKV infection/reactivation would allow for continued optimal immunosuppression to prevent graft rejection in these patients.

This study is the first clinical study to be conducted with AntiBKV and has been designed to evaluate the safety, tolerability, and pharmacokinetic of ascending doses of AntiBKV administered as 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.

Conditions: BK Virus Nephropathy
Being tested: AntiBKV, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AntiBKVBiological
AntiBKV neutralising antibody
PlaceboBiological
Solution with no active ingredients

Study groups in NCT05358106
Study group	Role	What they receive
AntiBKV neutralising antibody	Active comparator	AntiBKV infused i.v. over 30 minutes. Infusion parameters may be adjusted to bodyweight so that infusion rate does not exceed 60mg/kg per hour. AntiBKV will be administered as a single infusion in Part 1 or as 4 infusions administered 4 weeks apart in Part 2 (100, 500, 1000 or 2000 mg). Receives: Biological: AntiBKV
Placebo	Placebo comparator	Solution containing no active excipients, infused i.v. over 30 minutes as a single infusion in Part 1 or as 4 infusions administered 4 weeks apart in Part 2. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To assess the number of participants with treatment related adverse events following a single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in blood haematology values
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Haematology data will be summarised for each scheduled visit, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in blood biochemistry values
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Biochemistry data will be summarised for each scheduled visit, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in urinalysis values
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Urinalysis data will be summarised for each scheduled visit, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in blood pressure
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Blood pressure results will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in heart rate
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Heart rate will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in respiratory rate
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Respiration rate will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in body temperature
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Body temperature will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Participants with abnormal physical examination findings.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Abnormal physical examination findings during scheduled physical exams will be listed.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in P wave duration in electrocardiogram measurement
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
ECG parameters will be descriptively summarized for each scheduled timepoint, including observed values and change from baseline.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in PR interval in electrocardiogram measurement
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
ECG parameters will be descriptively summarized for each scheduled timepoint, including observed values and change from baseline.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Change in QRS duration in electrocardiogram measurement
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
ECG parameters will be descriptively summarized for each scheduled timepoint, including observed values and change from baseline.
Measured: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.

Secondary outcomes (6)

Pharmacokinetics measured by the maximum plasma concentration (Cmax)
To assess the pharmacokinetic profile of AntiBKV in healthy participants after single (Part 1 and first dose in Part 2) or multiple (Part 2) intravenous dose administration.
Measured: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the time of Cmax (Tmax)
To assess the pharmacokinetic profile of AntiBKV in healthy participants after single (Part 1 and first dose in Part 2) or multiple (Part 2) intravenous dose administration.
Measured: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the area under the curve (AUC)
To assess the pharmacokinetic profile of AntiBKV in healthy participants after single (Part 1 and first dose in Part 2) or multiple (Part 2) intravenous dose administration.
Measured: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the terminal elimination rate constant (λz)
To assess the pharmacokinetic profile of AntiBKV in healthy participants after single (Part 1 and first dose in Part 2) or multiple (Part 2) intravenous dose administration.
Measured: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the half life
To assess the pharmacokinetic profile of AntiBKV in healthy participants after single (Part 1 and first dose in Part 2) or multiple (Part 2) intravenous dose administration.
Measured: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Immunogenicity measured by anti-drug antibody (ADA) production
Samples will be tested for the presence of ADAs. ADA titers and the presence of neutralizing antibodies will be determined for ADA positive samples
Measured: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 20222 Apr 2023

First posted3 May 2022
Study start9 May 2022
Primary completion5 Dec 2022
Study completion2 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for BK Virus NephropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-blind, partially randomized, placebo-controlled study in healthy volunteers. Approximately 40 to 56 healthy adult participants are planned to be enrolled in 7 cohorts of 4 to 8 participants, randomized in a 3:1 ratio to receive AntiBKV or placebo
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05358106
Sponsor's protocol ID: MTx-AntiBKV-AU-1.02BKVI
Acronym: SAFE KIDNEY I
Status last verified: Jun 2023
First submitted: 23 Mar 2022
Last updated: 18 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The Sponsor, MEMO Therapeutics AG., will not be sharing data with anyone outside of MEMO Therapeutics AG and the CRO involved in the study.

Publications

Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
PubMed 39352862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Kidney Diseases, Kidney Injury
RecruitingPhase 3
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
BK Viremia, Kidney Transplant Infection
RecruitingObservational study
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
Nephropathy, Opportunistic Viral Infection
Not yet recruiting
Salivary Replication of BK Virus in Post-kidney Transplant
BK Virus, Salivary Replication
Not yet recruitingObservational study
Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia
BK Polyomavirus, Kidney Transplant

All BK Virus Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-blind, Partially Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Intravenous Doses of AntiBKV in Healthy Adult Volunteers.
ClinicalTrials.gov ID: NCT05358106
Acronym / sponsor ID: SAFE KIDNEY I / MTx-AntiBKV-AU-1.02BKVI
Conditions: BK Virus Nephropathy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Memo Therapeutics AGIndustry (pharma, biotech, devices)
Study start: 9 May 2022 (actual)
Primary completion: 5 Dec 2022 (actual)
Study completion: 2 Apr 2023 (actual)
First posted: 3 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Single-blind, partially randomized, placebo-controlled study in healthy volunteers. Approximately 40 to 56 healthy adult participants are planned to be enrolled in 7 cohorts of 4 to 8 participants, randomized in a 3:1 ratio to receive AntiBKV or placebo

Arm	Type	Receives
AntiBKV neutralising antibody	Active comparator	Biological: AntiBKVAntiBKV infused i.v. over 30 minutes. Infusion parameters may be adjusted to bodyweight so that infusion rate does not exceed 60mg/kg per hour. AntiBKV will be administered as a single infusion in Part 1 or as 4 infusions administered 4 weeks apart in Part 2 (100, 500, 1000 or 2000 mg).
Placebo	Placebo comparator	Biological: PlaceboSolution containing no active excipients, infused i.v. over 30 minutes as a single infusion in Part 1 or as 4 infusions administered 4 weeks apart in Part 2.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy male or female participants aged 18 years to 50 years at the time of consent
Ability to read, understand and provide written informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including lifestyle restrictions for the duration of the study
Healthy participants as established by medical history, laboratory examination, physical examination, vital signs, and ECG during screening and as per the clinical judgment of the investigator
Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive)

Key exclusion criteria (24 listed)

Participant with active SARS-CoV-2 infection
Participants tested positive for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)
History of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation.
History of any reaction to monoclonal antibodies.
History of allergic disease or reactions likely to be exacerbated by any component of the study drug, as assessed by the investigator, and/or known allergies to the trial product or its components.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AntiBKVAntiBKV neutralising antibody	Biological	AntiBKV neutralising antibody
PlaceboSolution with no active ingredients	Biological	Placebo

Primary outcome

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To assess the number of participants with treatment related adverse events following a single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants.
Change in blood haematology values
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Haematology data will be summarised for each scheduled visit, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Change in blood biochemistry values
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Biochemistry data will be summarised for each scheduled visit, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Change in urinalysis values
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Urinalysis data will be summarised for each scheduled visit, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Change in blood pressure
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Blood pressure results will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Change in heart rate
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Heart rate will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Change in respiratory rate
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Respiration rate will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Change in body temperature
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Body temperature will be summarized for each scheduled timepoint, including observed values, change from baseline, number of out-of-range values and number of clinically significant values.
Participants with abnormal physical examination findings.
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. Abnormal physical examination findings during scheduled physical exams will be listed.
Change in P wave duration in electrocardiogram measurement
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. ECG parameters will be descriptively summarized for each scheduled timepoint, including observed values and change from baseline.
Change in PR interval in electrocardiogram measurement
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. ECG parameters will be descriptively summarized for each scheduled timepoint, including observed values and change from baseline.
Change in QRS duration in electrocardiogram measurement
Time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
To evaluate the safety and tolerability of single ascending doses (Part 1) and multiple ascending doses (Part 2) of AntiBKV administered intravenously to healthy adult participants. ECG parameters will be descriptively summarized for each scheduled timepoint, including observed values and change from baseline.

6 secondary outcomes

Pharmacokinetics measured by the maximum plasma concentration (Cmax)
Time frame: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the time of Cmax (Tmax)
Time frame: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the area under the curve (AUC)
Time frame: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the terminal elimination rate constant (λz)
Time frame: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Pharmacokinetics measured by the half life
Time frame: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Immunogenicity measured by anti-drug antibody (ADA) production
Time frame: Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Derived from this study: PubMed 39352862Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
Individual participant dataSharing planned: No. The Sponsor, MEMO Therapeutics AG., will not be sharing data with anyone outside of MEMO Therapeutics AG and the CRO involved in the study.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jürgen Beck study director

Memo Therapeutics AG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AntiBKV in people with BK Virus Nephropathy, run by Memo Therapeutics AG at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358106, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.