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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05358106


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05358106
Ethics application status
Date submitted
23/03/2022
Date registered
3/05/2022
Date last updated
18/06/2023

Titles & IDs
Public title
Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.
Scientific 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.
Secondary ID [1] 0 0
MTx-AntiBKV-AU-1.02BKVI
Universal Trial Number (UTN)
Trial acronym
SAFE KIDNEY I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BK Virus Nephropathy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - AntiBKV
Other interventions - Placebo

Active Comparator: AntiBKV neutralising antibody - 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).

Placebo Comparator: Placebo - 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.


Other interventions: AntiBKV
AntiBKV neutralising antibody

Other interventions: Placebo
Solution with no active ingredients
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timepoint [1] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [2] 0 0
Change in blood haematology values
Timepoint [2] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [3] 0 0
Change in blood biochemistry values
Timepoint [3] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [4] 0 0
Change in urinalysis values
Timepoint [4] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [5] 0 0
Change in blood pressure
Timepoint [5] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [6] 0 0
Change in heart rate
Timepoint [6] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [7] 0 0
Change in respiratory rate
Timepoint [7] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [8] 0 0
Change in body temperature
Timepoint [8] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [9] 0 0
Participants with abnormal physical examination findings.
Timepoint [9] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [10] 0 0
Change in P wave duration in electrocardiogram measurement
Timepoint [10] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [11] 0 0
Change in PR interval in electrocardiogram measurement
Timepoint [11] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Primary outcome [12] 0 0
Change in QRS duration in electrocardiogram measurement
Timepoint [12] 0 0
Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
Secondary outcome [1] 0 0
Pharmacokinetics measured by the maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Secondary outcome [2] 0 0
Pharmacokinetics measured by the time of Cmax (Tmax)
Timepoint [2] 0 0
Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Secondary outcome [3] 0 0
Pharmacokinetics measured by the area under the curve (AUC)
Timepoint [3] 0 0
Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Secondary outcome [4] 0 0
Pharmacokinetics measured by the terminal elimination rate constant (?z)
Timepoint [4] 0 0
Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Secondary outcome [5] 0 0
Pharmacokinetics measured by the half life
Timepoint [5] 0 0
Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.
Secondary outcome [6] 0 0
Immunogenicity measured by anti-drug antibody (ADA) production
Timepoint [6] 0 0
Treatment Day 1 to final visit (Day 113) for Part 1 and final visit (Day 197) for Part 2.

Eligibility
Key inclusion criteria
1. Healthy male or female participants aged 18 years to 50 years at the time of consent

2. Ability to read, understand and provide written informed consent

3. 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

4. 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

5. Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive)

6. 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.

7. 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.

8. Accessible veins in the forearms for venepuncture and/or intravenous cannulation
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participant with active SARS-CoV-2 infection

2. Participants tested positive for human immunodeficiency virus (HIV antibody screen),
Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)

3. 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.

4. History of any reaction to monoclonal antibodies.

5. 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.

6. 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.

7. 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.

8. Acute illness (moderate or severe) and/or fever (body temperature = 38 °C) during the
72 hours prior to any planned study drug application.

9. 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.

10. Receipt of immunoglobulin or blood products within 6 months prior to enrolment.

11. Receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever
is longer.

12. Planned surgery (excluding minor procedures such as tooth extraction or incision and
drainage) during the course of the study.

13. 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.

14. History of alcoholism (>10 drinks/week) or drug addiction within 1 year prior to
screening.

15. 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.

16. 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.

17. 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.

18. 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).

19. Pregnant, lactating, or planned pregnancy during the study period.

20. Inability to comply with the study protocol in the opinion of the investigator.

21. 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.

22. 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.

23. Participant has clinically significant 12-lead ECG abnormalities at screening.

24. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/04/2023
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Memo Therapeutics AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05358106
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jürgen Beck
Address 0 0
Memo Therapeutics AG
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries




Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 90
CMAX Clinical Research Pty Ltd
Recruitment postcode(s) [1] 94
5000
Funding & Sponsors
Funding source category [1] 76
Commercial sector/Industry
Name [1] 76
Memo Therapeutics AG
Address [1] 76
Wagistrasse 27 8952 Schlieren, Switzerland
Country [1] 76
Switzerland
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Memo Therapeutics AG
Primary sponsor address
Wagistrasse 27
8952 Schlieren, Switzerland
Primary sponsor country
Switzerland
Secondary sponsor category [1] 75
Commercial sector/Industry
Name [1] 75
Accelagen Pty Ltd
Address [1] 75
Suite 2.02 785 Toorak Road, Hawthorn East Victoria, Australia 3123
Country [1] 75
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 48
Bellberry Limited
Address [1] 48
123 Glen Osmond Rd, Eastwood SA 5063
Country [1] 48
Australia
Date submitted for ethics approval [1] 48
23/03/2022
Approval date [1] 48
27/04/2022
Ethics approval number [1] 48
 
Public notes

Contacts
Principal investigator
Title 333 0
Dr
Name 333 0
Jonathan Newchurch
Address 333 0
CMAX Clinical Research Pty Ltd
Country 333 0
Australia
Phone 333 0
0423223756
Fax 333 0
Email 333 0
jnewchurch@gmail.com
Contact person for public queries
Title 334 0
Mr
Name 334 0
Greg Plunkett
Address 334 0
Suite 2.02 785 Toorak Road, Hawthorn East Victoria, Australia 3123
Country 334 0
Australia
Phone 334 0
+61 3 9114 2274
Fax 334 0
Email 334 0
greg.plunkett@accelagen.com.au
Contact person for scientific queries
Title 335 0
Dr
Name 335 0
Jonathan Newchurch
Address 335 0
CMAX Clinical Research Pty Ltd
Country 335 0
Australia
Phone 335 0
0423223756
Fax 335 0
Email 335 0
jnewchurch@gmail.com