NL-OMON51485撤回不适用
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 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Summary of Key Inclusion and
排除标准
- •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.
- •* Part B (participants with SLE only): Diagnosis of adult SLE according to the
- •American College of Rheumatology classification criteria for at least 6 months
- •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
- •(simplified diagnostic criteria) and must have completed induction therapy with
- •standard of care (eg, steroids) and be on maintenance therapy (eg, azathioprine
- •low dose steroids).
研究者
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