Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers. (NCT05358106) | Clinical Trial Compass
CompletedPhase 1
Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.
Australia40 participantsStarted 2022-05-09
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
2
Change in blood haematology values
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
3
Change in blood biochemistry values
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
4
Change in urinalysis values
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
5
Change in blood pressure
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
6
Change in heart rate
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
✓. Accessible veins in the forearms for venepuncture and/or intravenous cannulation
Exclusion criteria
✕. 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.
✕. 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.
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
8
Change in body temperature
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
9
Participants with abnormal physical examination findings.
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
10
Change in P wave duration in electrocardiogram measurement
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
11
Change in PR interval in electrocardiogram measurement
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.
12
Change in QRS duration in electrocardiogram measurement
Timeframe: Screening (Day -1) to final visit post-treatment (Day 113) for Part 1 and final visit post-treatment (Day 197) for Part 2.