A phase 1, first-in-human, 2-part, randomized, double-blind, placebo controlled, single ascending dose and sequential, open-label, multiple ascending dose study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and participants with autoimmune disease(s)

Withdrawn

• Conditions: AIH; autoimmune disease(s); autoimmune hepatitis; 10019654; 10003816

• Registration Number: NL-OMON51485
• Lead Sponsor: Parexel Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

Summary of Key Inclusion and

Exclusion Criteria

Inclusion Criteria
Male or female participant between 18 and 55 years of age, inclusive, at the
screening
visit (Part A and Part B [participants with AIH, FSGS, and AA]) or between 18
and
75 years of age, inclusive, at the screening visit (Part B [participants with
SLE]). Body
mass index between 17 and 35 kg/m2, inclusive, at the screening visit.
Additional inclusion criteria:
* Part A: Healthy, as determined by prestudy medical evaluation (medical
history,
physical examination, vital signs, 12-lead electrocardiogram, and clinical
laboratory
evaluations), as judged by the principal investigator.
* Part B (participants with SLE only): Diagnosis of adult SLE according to the
2019
American College of Rheumatology classification criteria for at least 6 months
prior
to signing the informed consent form (ICF) and an estimated glomerular
filtration rate
(eGFR) >= 30 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease
Epidemiology Collaboration [CKD-EPI] formula [2021]).
* Part B (participants with AIH only): Adult meeting criteria for autoimmune
hepatitis
(simplified diagnostic criteria) and must have completed induction therapy with
standard of care (eg, steroids) and be on maintenance therapy (eg, azathioprine
and/or
low dose steroids).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objectives and Endpoints - Part A (Single Ascending Dose)<br /><br>Objectives Endpoints<br /><br>Primary:<br /><br>· To evaluate the safety and tolerability of VIS171.<br /><br>Primary endpoint:<br /><br>· Incidence and severity of TEAEs.<br /><br><br /><br>Objectives and Endpoints - Part B (Multiple Ascending Dose)<br /><br>Objectives Endpoints<br /><br>Primary:<br /><br>· To Endpoint evaluate the safety and tolerability of VIS171.<br /><br>Primary:<br /><br>· Incidence and severity of TEAEs.</p><br>