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临床试验/NL-OMON52051
NL-OMON52051已完成不适用

A first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of INS-3001 in healthy subjects and patients with moderate aortic valve stenosis - SAD, MAD FIH study to assess safety, tolerability, PK and PD of INS-3001

Vifor (International) Inc.0 个研究点目标入组 30 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
30
研究概览入排标准研究者记录与标识符相似试验

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 64（—）

入选标准

  • •A1. Age : 21 to 60 years, inclusive, at screening.
  • •A2. Body mass index (BMI) : 18.0 to 30.0 kg/m2, inclusive, at screening.
  • •A3. Being male or female; females must be of nonchildbearing potential (ie,
  • •surgically sterilized [ie, hysterectomy, bilateral salpingectomy, or bilateral
  • •oophorectomy], physiologically incapable of becoming pregnant, or at least 1
  • •year postmenopausal [amenorrhea duration of >=12 consecutive months]).
  • •A4. Females must not be pregnant or lactating; nonpregnancy will be confirmed
  • •for all females by a serum pregnancy test conducted at screening, at admission,
  • •and at follow-up.
  • •A5. Male subjects, if not surgically sterilized (ie, vasectomized), must agree
  • •to use adequate contraception when having intercourse with a female sexual
  • •partner of childbearing potential and to not donate sperm from admission to the
  • •clinical site until 90 days after the follow up visit. See Section 3.4.8.2 for
  • •the full definition of adequate contraception.
  • •A6. In good physical and mental health on the basis of medical history,
  • •physical examination, and routine laboratory measurements (ie, without major or
  • •clinically relevant pathology), as judged by the Investigator.
  • •A7. Normal arterial blood pressure (systolic blood pressure of 90 to 140 mmHg,
  • •inclusive, and diastolic blood pressure of 45 to 90 mmHg, inclusive) and pulse
  • •rate (40 to 100 beats per minute, inclusive). Measurement of blood pressure
  • •and/or pulse may be repeated if in the judgment of the Investigator there is a
  • •reason to believe the initial result is inaccurate (eg, white coat
  • •hypertension).
  • •A8. Computerized (12-lead) ECG recording without signs of clinically relevant
  • •pathology, as judged by the Investigator. The ECG may be repeated if in the
  • •judgment of the Investigator there is a reason to believe the initial result is
  • •inaccurate.
  • •A9. Willing and able to abstain from alcohol for 72 hours (3 days) prior to
  • •screening and from 72 hours prior to study drug administration until the last
  • •PK blood sampling.
  • •A10. Willing and able to abstain from methylxanthine-containing beverages
  • •(coffee, tea, cola, or other caffeinated beverage) from 48 hours (2 days) prior
  • •to study drug administration until the last PK blood sampling.
  • •A11. Willing and able to abstain from herbal medications or dietary supplements
  • •(eg, St. John*s Wort or ginkgo biloba), vitamin preparations, grapefruit or
  • •grapefruit juice, or Seville oranges from 14 days prior to administration of
  • •the study drug until follow up.
  • •A12. Willing and able to understand and comply with the protocol requirements
  • •and instructions and likely to complete the study as planned.
  • •A13. Willing and able to read, understand, and sign the ICF.
  • •B1. Age : >55 years at screening.
  • •B2. BMI : 18.0 to 35.0 kg/m2, inclusive, at screening.
  • •B3. Being male or female; females must be of nonchildbearing potential (ie,
  • •surgically sterilized [ie, hysterectomy, bilateral salpingectomy, or bilateral
  • •oophorectomy], physiologically incapable of becoming pregnant, or at least 1
  • •year postmenopausal [amenorrhea duration of >=12 consecutive months and
  • •confirmed by a follicle stimulating hormone {FSH} test at screening]).
  • •B4. Females must not be pregnant or lactating; nonpregnancy will be confirmed
  • •for all females by a serum or urine pregnancy test conducted at screen

排除标准

  • •A1. Treatment with prescription medications within 14 days prior to study drug
  • •administration. An exception is made for vaccines against SARS-CoV-2, which
  • •will be allowed but must be discussed with the Investigator to mitigate against
  • •any interruptions to trial-related procedures and assessments. Potential
  • •subjects should only stop any prescribed medication at the direction of a
  • •A2. Treatment with nonprescription medications within 14 days prior to study
  • •drug administration. An exception is made for paracetamol, which is allowed up
  • •to admission to the clinical site. Potential subjects should consult a
  • •physician before stopping any regular treatment with nonprescription medication.
  • •A3. Using tobacco products within 3 months prior to study drug administration.
  • •A4. History of alcohol or drug abuse or addiction within 2 years prior to study
  • •drug administration.
  • •A5. Regular consumption of more than 14 units of alcohol per week for females
  • •and more than 21 units of alcohol per week for males (1 unit equals 250 mL of
  • •beer, 100 mL of wine, or 35 mL of spirits).
  • •A6. Regular consumption of more than 8 cups of methylxanthine-containing
  • •beverages (coffee, tea, cola, or other caffeinated beverage) per day (1 cup
  • •equals 250 mL).
  • •A7. Participation in a clinical study involving administration of an
  • •investigational or a marketed drug within 3 months prior to screening.
  • •Participation in more than 4 other drug studies in the 12 months prior to study
  • •drug administration in the current study.
  • •A8. Blood donation or a significant loss of blood (>450 mL) within 60 days
  • •prior to study drug administration or donation of more than 1 unit of plasma
  • •within 7 days prior to screening.
  • •A9. Employee of PRA Health Sciences (PRA) or the Sponsor.
  • •A10. History of any illness or condition that, in the opinion of the
  • •Investigator, might confound the results of the study or pose an additional
  • •risk when administering the study drug to the subject.
  • •A11. Positive drug or alcohol screen (opiates, methadone, cocaine, amphetamines
  • •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma
  • •hydroxybutyric acid, tricyclic antidepressants, cotinine, or alcohol) at
  • •screening or at admission to the clinical site.
  • •A12. Previous participation in the current study.
  • •A13. Positive result at screening for any of the following infectious disease
  • •tests: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies,
  • •or human immunodeficiency virus (HIV) 1 and 2 antibodies.
  • •A14. Positive PCR test for SARS CoV-2 at admission to the clinical site.
  • •A15. Unsuitable veins for infusion or blood sampling.
  • •A16. History of relevant drug and/or food allergies.
  • •A17. Illness within 5 days prior to study drug administration (*illness* is
  • •defined as an acute [serious or non-serious] condition [eg, the flu or the
  • •common cold]).
  • •B1. Rheumatic or unicuspid aortic valves.
  • •B2. Patients with aortic sclerosis, mild or severe aortic stenosis, or absence
  • •of aortic valve calcification (ie, parameters outside the limits defined in the
  • •inclusion criteria).
  • •B3. Severe mitral or aortic regurgitation.
  • •B4. Severe mitral stenosis.
  • •B5. History of aortic valve replacement.
  • 另有 3 项未显示

研究者

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