A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune … (NCT05418101) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)
Bulgaria61 participantsStarted 2022-04-28
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion Criteria:
Exclusion criteria for both Part A and Part B:
Prior and Concomitant Therapy
* Receipt of high dose corticosteroid therapy within 4 weeks prior to screening.
* Receipt of belimumab within 6 months prior to screening.
* History of treatment w…
What they're measuring
1
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
Timeframe: Part A: From screening up to Day 29; Part B: From screening up to Day 71
Trial details
NCT IDNCT05418101
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.