Autoimmune Diseases
Conditions
Keywords
Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, Healthy participants
Brief summary
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).
Detailed description
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.
Interventions
DRUGVIS171
Participants will receive VIS171 via SC route of administration.
DRUGPlacebo
Participants will receive Placebo via SC route of administration
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Part A will be double masked; Part B is open label.
Intervention model description
This phase 1 study has two parts. Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Part B is an open-label, MAD basket assessment of SC VIS171 in participants with an autoimmune inflammatory disease
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for both Part A and Part B: * Male or female participant between 18 and 55 years of age, inclusive, at the screening visit (Part A and Part B \[participants with selected autoimmune diseases\]) or between 18 and 75 years of age, inclusive, at the screening visit (Part B \[participants with specific autoimmune disease\]). * Body mass index between 17 and 35 kg/m\^2. * Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 2 years or surgically sterile for at least 3 months. * Male participants with female partners of childbearing potential must agree to use double barrier contraception or abstain from sex during the study and until 90 days following the last dose of study intervention. Additional inclusion criterion for Part A: \- Healthy, as determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations). Additional inclusion criteria for Part B (participants with specific autoimmune disease\[s\]): * Diagnosis of a specified autoimmune disease based on standard criteria for the condition. * Other criteria may apply depending on the autoimmune condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs) | Part A: From screening up to Day 29; Part B: From screening up to Day 71 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 | 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) | 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 | 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 | Part A: From baseline up to Day 29 |
| Part B: Area under the concentration-time curve over the dosing interval at steady-state (AUCtau) | Part B: From baseline up to Day 71 |
| Part A and Part B: Number of participants with Anti-drug antibodies (ADA) positive for VIS171 | Part A: Day 1, 15, and 29; Part B: Day 1, 15, 29, 43, and 71 |
Countries
Bulgaria, Germany, Moldova, Netherlands, New Zealand
Contacts
PRINCIPAL_INVESTIGATORAsher Schachter, MD
Visterra, Inc.
Outcome results
None listed