NCT01350960终止1 期
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)
Santaris Pharma A/S1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose is to study Safety and Tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects and subjects with heterozygous Familial Hypercholesterolemia
- •Healthy male or female subjects, age 18 to 65 years, inclusive will be enrolled in Cohorts 1 through
- •In Cohort 5, male or female subjects with heterozygous Familial Hypercholesterolemia, confirmed through genetic testing, without a history of cardiovascular disease (e.g. coronary artery, peripheral artery or cerebrovascular disease), hypertension or diabetes mellitus age 18-45 years, inclusive, will be enrolled.
- •BMI of 18-33 kg/m2
- •Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:
- •LDL ≥.3.24 mmol/L (≥ 100 mg/dL)
- •Triglycerides (fasted) < 4.5 mmol/L (< 398 mg/dL)
- •ALT within normal limits for healthy subjects and ALT < 2 x ULN for FH subjects
排除标准
- •Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
- •History or presence of malignancy within the past year is an exclusion criterion. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
- •Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
- •Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study. For the FH subjects statin therapy (and other lipid lowering therapies) will be prohibited within 4 weeks prior to the first study drug administration.
- •Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies. An exception can be made for medication or supplements that in the opinion of both the investigator and the Sponsor do not complicate or compromise the study or interfere with the study objectives.
- •Positive results on the following Screening laboratory tests: urine or serum pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
研究组 & 干预措施
Cohort 4
Experimental
10 mg/kg in Healthy subjects
干预措施: SPC5001 (Drug)
Cohort 5
Experimental
TBD mg/kg in FH subjects
干预措施: SPC5001 (Drug)
saline 0.9%
Placebo Comparator
干预措施: Saline 0.9% (Drug)
Cohort 1
Experimental
0.5 mg/kg in Healthy Subjects
干预措施: SPC5001 (Drug)
Cohort 2
Experimental
1.5 mg/kg in Healthy subjects
干预措施: SPC5001 (Drug)
Cohort 3
Experimental
5.0 mg/kg in Healthy subjects
干预措施: SPC5001 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Regularly over 78 days
Safety evaluation will assess adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring
次要结局
- Lipid lowering effect(Through out the study)
- Area under the plasma concentration versus time curve (AUC) of SPC5001(up to 78 days)
- Peak Plasma Concentration (Cmax) of SPC5001(up to 78 days)
研究者
研究点 (1)
Loading locations...
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