A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Ad… (NCT06212804) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants
United States54 participantsStarted 2023-11-21
Plain-language summary
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Male or female participant between 18 to 55 years of age, inclusive, at the screening visit.
✓. Non-Japanese participant: Participant does not meet the criteria specified below for 'Japanese Participant'.
✓. Japanese participant: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant's 4 grandparents were born in Japan and recognized to be 'Japanese').
✓. Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit.
✓. Total body weight between 50.0 and 120.0 kg, inclusive, at the screening visit.
✓. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
✓. Willing and able to participate in the study for the defined duration of the study.
✓. Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 1 year or surgically sterile for at least 3 months, or will agree to use highly effective methods of contraception from the period prior to study enrollment until 30 days after Day 56; women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at baseline prior to administration of the study intervention.
Exclusion criteria
✕. Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Timeframe: From study intervention administration (Day 1) up to end of follow-up (Day 71)
2
Wong-Baker FACES Pain Rating Scale
Timeframe: Day 1 (1 and 4 hours post-dose), Day 2 (24 hours post-dose), and on Days 3 and 29
Trial details
NCT IDNCT06212804
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
✕. Participant is participating in another clinical study of any investigational drug, device, or intervention or has received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, before baseline (Day -1).
✕. Previous receipt of antibody or biologic therapy.
✕. History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 SC injection formulation.
✕. Blood pressure \> 160/100 mmHg or \< 90/50 mmHg (may be repeated once if abnormal), at the screening visit or Day -1.
✕. History of any infection requiring hospitalization or treatment with antivirals, antibiotics, or systemic antifungals within 3 months prior to screening.
✕. Received a vaccination, other than COVID-19 vaccination, during the 30 days prior to administration of the first dose of study intervention. A COVID-19 vaccination cannot be received within 7 days prior to the first dose of study intervention and until 14 days after the last dose.
✕. Has received any prescription or nonprescription (over-the-counter) medication during the last 30 days or 5 half-lives, whichever is longer, preceding baseline (Day -1), with the exception of acetaminophen, ibuprofen, naproxen (or other over-the-counter nonsteroidal anti-inflammatory drugs \[NSAID\]), hormonal contraceptives, topical medications, vitamins, and dietary or herbal remedies.