First in Human Study to Assess Safety of VIS649 in Healthy Subjects (NCT03719443) | Clinical Trial Compass
CompletedPhase 1
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
United States51 participantsStarted 2018-10-09
Plain-language summary
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects.
VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
The study will enroll up to 45 subjects and will be conducted in up to 5 sequential dosing cohorts at four different dose levels, enrolling 9 subjects per cohort. Subjects will be randomized to VIS649 or placebo in a ratio of 7:2 (7 active, 2 placebo). Safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the initial cohorts will be assessed.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to performing any of the Screening Visit procedures and be able to sign and date an appropriate Health Insurance Portability and Accountability Act (HIPAA) authorization form or subject privacy form, if appropriate.
✓. Male and female subjects between 18 to 55 years of age, inclusive, at the Screening Visit.
✓. For Japanese subjects: Subject is of Japanese descent as evidenced by verbal confirmation of familial heritage (a subject has all four Japanese grandparents born in Japan).
✓. For non-Japanese subjects: Subjects must be of non-Asian descent, as evidenced by verbal confirmation that all four grandparents are non-Asian.
✓. The following applies to female subjects:
✓. For male, subject and/or his partner must use a highly effective form of contraception (i.e., double-barrier as described above, have had a vasectomy, or have a female partner of non childbearing potential) or agree to abstinence following study drug dosing, through the end of the subject's participation in the study. Male subjects must also agree to not donate sperm for the duration of their participation in the study, following study drug dosing.
✓. Screening laboratory values must meet the following criteria:
What they're measuring
1
Overall Summary of Treatment Emergent Adverse Events
Timeframe: Baseline to day 112
Trial details
NCT IDNCT03719443
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
✓. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the Screening Visit.
Exclusion criteria
✕. 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 five half-lives, whichever is longer, before Baseline (Day -1).
✕. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study.
✕. Subject 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 (i.e., carcinoma in situ) are not exclusionary.
✕. Subject has a history or presence of proteinuria, chronic kidney disease, disease requiring immunosuppressive therapy (including systemic steroids), or is considered to be immunosuppressed for any other reason.
✕. Previous receipt of antibody or biologic therapy whether licensed or investigational (immunoglobulin products, monoclonal antibodies or antibody fragments) within 30 days prior to dosing or 5 half-lives within the dose of Investigational medicinal products (IMP), whichever is longer.
✕. History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
✕. Blood pressure \>160/100 mmHg or \<90/50 mmHg (may be repeated once if abnormal), at the Screening visit and Day 1.
✕. Known hypoglobulinemia disorder (i.e., common variable immunodeficiency), X linked agammaglobulinemia, selective IgA deficiency, selective IgM deficiency).