NL-OMON51485
Withdrawn
Not Applicable
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) - VIS171
Parexel Nederland0 sites3 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- AIH
- Sponsor
- Parexel Nederland
- Enrollment
- 3
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •visit (Part A and Part B \[participants with AIH, FSGS, and AA]) or between 18
- •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
- •physical examination, vital signs, 12\-lead electrocardiogram, and clinical
- •evaluations), as judged by the principal investigator.
Outcomes
Primary Outcomes
Not specified
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