临床试验/NCT03165864

NCT03165864已完成1 期

A Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 702843 Administered Subcutaneously to Healthy Volunteers

Ionis Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2017年5月9日最近更新: 2019年1月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Ionis Pharmaceuticals, Inc.
入组人数: 36
试验地点: 1
主要终点: Incidence and severity of adverse events that are related to treatment with IONIS TMPRSS6-Lrx

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers

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: Double (Participant, 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

•Must have given written informed consent and be able to comply with all study requirements
•Healthy males or females aged 18-65 inclusive at the time of Informed Consent
•Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
•Males must be surgically sterile, abstinent or using an acceptable contraceptive method
•BMI < 32 kg/m2

排除标准

•Clinically significant abnormalities in medical history or physical examination
•Clinically significant lab abnormalities that would render a subject unsuitable for inclusion
•Known history or positive test for HIV, HCV, or HBV
•Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
•Smoking > 10 cigarettes per day
•Regular excessive use of alcohol within 6 months of screening
•Current use of concomitant medications other than occasional acetaminophen (paracetamol) or ibuprofen unless approved by Sponsor Medical Monitor
•Considered unsuitable for inclusion by the Investigator or Sponsor

研究组 & 干预措施

IONIS TMPRSS6-Lrx

Experimental

Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously

干预措施: IONIS TMPRSS6-Lrx (Drug)

Placebo

Placebo Comparator

Saline .9%

干预措施: Placebo (Other)

结局指标

主要结局

Incidence and severity of adverse events that are related to treatment with IONIS TMPRSS6-Lrx

时间窗: Up to 148 Days

The safety and tolerability of single and multiple doses of IONIS TMPRSS6-Lrx will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with IONIS TMPRSS6-Lrx

次要结局

Pharmacokinetics after single and multiple doses of IONIS TMPRSS6-Lrx (maximum observed drug concentration or Cmax)(Up to 148 Days)
Pharmacokinetics after single and multiple doses of IONIS TMPRSS6-Lrx (Plasma terminal elimination half-life (t1/2λz)(Up to 148 Days)
Pharmacokinetics after single and multiple doses of IONIS TMPRSS6-Lrx (time taken to reach maximal concentration or Tmax)(Up to 148 Days)
Pharmacokinetics after single and multiple doses of IONIS TMPRSS6-Lrx (Partial areas under the plasma concentration-time curve from zero time (predose) to selected times (t) after the subcutaneous administration (AUCt)(Up to 148 Days)
Pharmacokinetics after single and multiple doses of IONIS TMPRSS6-Lrx (Percentage of the administered dose excreted in urine (% Dose Excreted)(Up to 148 Days)

研究者

发起方

Ionis Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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