Status:
COMPLETED
Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.
Lead Sponsor:
Memo Therapeutics AG
Conditions:
BK Virus Nephropathy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 receiv...
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 immunocomp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05358106
Start Date
May 9 2022
End Date
April 2 2023
Last Update
June 18 2023
Active Locations (1)
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1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000