NL-OMON36203已完成不适用
A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC5001 Administered to Healthy Subjects and Subjects with Familial Hypercholesterolemia (FH) - SPC5001 in healthy subjects and subjects with FH
Santaris0 个研究点目标入组 48 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
- 已完成
- 发起方
- 入组人数
- 48
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
- •Age: 18-65 years (healthy subjects)
- •Age: 18-45 years (FH subjects)
- •BMI: 18-33 kg/m2
- •LDL >= 2.59 mmol/L (>=100 mg/dL)
- •Triglycerides (fasted) < 4.5 mmol/L (<398 mg/dL)
- •ALT within normal limits (healthy subjects)
- •ALT <= 2x ULN (FH subjects)
- •Subjects with FH without a history of cardiovascular disease, hypertension or diabetes mellitus can be enrolled in cohort 5.
排除标准
- •Any uncontrolled or active major systemic disease.
- •History or presence of malignancy in the past year.
- •Active acute or chronic infection.
- •Clinically significant illness within 30 days prior to the planned first drug administration.
- •See protocol for other criteria.
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