This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).
This is a multicenter, 2-part combined Single ascending dose (SAD) and Multiple ascending dose (MAD) First-in-Human (FIH) study to investigate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (Part A - SAD) and in participants with autoimmune inflammatory disease(s) (Part B - MAD). Part A: Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Up to 5 cohorts are planned, each comprising 8 participants (6 VIS171 and 2 placebo). Part B: Part B is an open-label, MAD basket assessment of SC VIS171 in participants with autoimmune inflammatory disease(s). Two to 3 cohorts are planned, each comprising 12 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
UMHAT
Plovdiv, Bulgaria
Ambulatory for Specialized Medical Help - skin and venereal diseases
Sofia, Bulgaria
Comac Medical Ltd
Sofia, Bulgaria
MBAL Sveta Sofia
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
Time frame: Part A: From screening up to Day 29; Part B: From screening up to Day 71
Part A and Part B: Mean change from baseline in absolute number (cells/μL) for Treg, helper T cells, cytotoxic T cells and natural killer cells
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Mean change from baseline in percentage for Treg, helper T cells, cytotoxic T cells and natural killer cells
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Maximum (peak) plasma VIS171 concentration (Cmax) over time
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A and Part B: Time of maximum (peak) plasma VIS171 concentration (tmax)
Time frame: Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Part A: Area under the concentration-time curve from time zero to the last observable concentration (AUClast) of VIS171
Time frame: Part A: From baseline up to Day 29
Part A: Area under the concentration-time curve from time zero to infinity (AUC∞) for VIS171 concentration
Time frame: Part A: From baseline up to Day 29
Part B: Area under the concentration-time curve over the dosing interval at steady-state (AUCtau)
Time frame: Part B: From baseline up to Day 71
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Sofia, Bulgaria
Diagnostic and Consultative Center Convex EOOD
Sofia, Bulgaria
Universitaetsklinikum Bonn AöR
Bonn, Germany
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Rheinland-Pfalz, Germany
Clinical republican Hospital
Chisinau, Moldova
Radboud University Medical Center
Gelderland, Netherlands
New Zealand Clinical Research
Christchurch, New Zealand
Part A and Part B: Number of participants with Anti-drug antibodies (ADA) positive for VIS171
Time frame: Part A: Day 1, 15, and 29; Part B: Day 1, 15, 29, 43, and 71