healthy participants
Conditions
Interventions
Investigational Medicinal Product 1: VIS171
500, 1000 or 1500 ug is administered subcutaneously in the abdomen as a single dose.
Investigational Medicinal Product 2: Placebo
Placebo is administered s
Sponsors
Watsuji Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female participant between 18 and 55 years of age, inclusive, at the screening visit. Body mass index between 17 and 30 kg/m2, inclusive, at the screening visit. Participant must be of Japanese descent. A participant will be considered to be of Japanese ancestry based on verbal confirmation of familial heritage (a participants 4 grandparents were born in Japan and recognized to be Japanese). Healthy, as determined by pretrial medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluations), as judged by the principal investigator. Other protocol defined inclusion criteria should be applied
Exclusion criteria
Exclusion criteria: Receipt of blood products within 6 months prior to screening, or receipt of any medication classified as an antibody with human Fc moieties at any point in their known history. History of hypersensitivity to any component of the investigational medicinal product. Participants with uncontrolled hypertension (systolic blood pressure [SBP] >= 140 mmHg, diastolic blood pressure [DBP] >= 90 mmHg in any position) or symptomatic hypotension, any chronic infectious disease, or participants with a positive urine drug or alcohol breath screen test result at screening or baseline. Current symptoms of infection, diagnosis of Coronavirus Disease 2019 (COVID-19) (reverse transcription polymerase chain reaction [RT-PCR], antigen testing, or clinical diagnosis) in 21 days prior to screening, or ongoing diagnosis of Long COVID symptoms due to a prior COVID-19 infection. Received COVID-19 or influenza vaccination, during the 14 days prior to administration of the dose of study intervention. (Participants must be willing to abstain from receiving additional COVID-19 or influenza vaccinations within 14 days after the dose of study intervention. Other vaccination will be allowed as per local regulations.) Other protocol defined exclusion criteria should be applied
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of TEAEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change from baseline in immune cell types, including the following: Absolute number of Treg and frequency %Treg/CD4+ cells. Absolute number and frequency (%) of T helper cells, cytotoxic T cells, and NK cells 2)Pharmacokinetic parameters: Cmax tmax AUClast AUCinfinity 3)Evaluation of serum ADA over time. | — |
Contacts
Public ContactjRCT inquiry reception center EPS Corporation
EPS Corporation
Outcome results
None listed