EUCTR2011-003808-20-DE进行中（未招募）不适用
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EV-077-3201-2TBS in Healthy Subjects and Type 2 Diabetic Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Evolva SA
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All Parts (A, B and C)
- •1.Informed consent obtained before any trial-related activities.
- •2.A male with a partner of childbearing potential must only be allowed to participate if:
- •he and his partner are willing to use a medically acceptable method of birth control (e.g. condom in combination with hormonal contraception or intrauterine device, or a diaphragm with spermicide) during the study and for 3 months after participation in the study, or
- •he is vasectomized (> 6 months), or
- •he has a sterilized partner (> 6 months), or
- •he is abstinent during the study and for 3 months after participation in the study.
- •Parts A and B only
- •3.Healthy male subjects aged 18 to 50 inclusive.
- •4.Body weight 70 to 90 kg inclusive.
- •Part C only
- •5.Male or female subjects aged 18 to 70 years inclusive. (NB. All females must be of non-reproductive potential, i.e. post-menopausal, post-hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- •6.Body mass index (BMI) between 25.0 and 40.0 kg/m2 (both inclusive).
- •7.Subjects with type 2 diabetes mellitus according to American Diabetes Association (ADA) definition for a duration of at least 3 years, on a stable therapy with oral anti-diabetic drugs (OAD) or with insulin, with or without one or two OADs or a glucagon like peptide-1 (GLP-1) agonist, or glitazones. Stable baseline therapy is defined as unchanged dose regimen for at least 3 months before administration of the study drug.
- •8.HbA1c = 6.0 and = 9.0 %.
- •9.History of hyperlipidemia, with either elevated LDL cholesterol (>140 mg/dL) without therapy, or treatment with statins (NB. Patients on statin therapy must have a 2 week wash-out before they can enter the study).
- •10.History of hypertension, either with systolic blood pressure levels between 140 to 160 mmHg without treatment, or treatment with ACE inhibitors or ARB, which should be stable over the previous 3 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
- •All Parts (A, B and C)
- •1.Informed consent obtained before any trial-related activities.
- •2.A male with a partner of childbearing potential must only be allowed to participate if:
- •he and his partner are willing to use a medically acceptable method of birth control (e.g. condom in combination with hormonal contraception or intrauterine device, or a diaphragm with spermicide) during the study and for 3 months after participation in the study, or
- •he is vasectomized (> 6 months), or
- •he has a sterilized partner (> 6 months), or
- •he is abstinent during the study and for 3 months after participation in the study.
- •Parts A and B only
- •3.Healthy male subjects aged 18 to 50 inclusive.
- •4.Body weight 70 to 90 kg inclusive.
- •Part C only
- •5.Male or female subjects aged 18 to 70 years inclusive. (NB. All females must be of non-reproductive potential, i.e. post-menopausal, post-hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- •6.Body mass index (BMI) between 25.0 and 40.0 kg/m2 (both inclusive).
- •7.Subjects with type 2 diabetes mellitus according to American Diabetes Association (ADA) definition for a duration of at least 3 years, on a stable therapy with oral anti-diabetic drugs (OAD) or with insulin, with or without one or two OADs or a glucagon like peptide-1 (GLP-1) agonist, or glitazones. Stable baseline therapy is defined as unchanged dose regimen for at least 3 months before administration of the study drug.
- •8.HbA1c = 6.0 and = 9.0 %.
- •9.History of hyperlipidemia, with either elevated LDL cholesterol (>140 mg/dL) without therapy, or treatment with statins (NB. Patients on statin therapy must have a 2 week wash-out before they can enter the study).
- •10.History of hypertension, either with systolic blood pressure levels between 140 to 160 mmHg without treatment, or treatment with ACE inhibitors or ARB, which should be stable over the previous 3 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •All Parts (A, B and C)
- •1.Employees or personnel affiliated with the Sponsor or Investigator.
- •2.Previous participation (randomisation) in this trial.
- •3.The intake of any investigational drug within one month or five half-lives, whatever is longer, before administration of study drug.
- •4.A history of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator.
- •5.Clinically significant acute illness within 2 weeks before administration of study drug, including severe infections, as judged by the Investigator.
- •6.Abnormal and clinically significant ECG at screening.
- •7.Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening.
- •8.Intake of paracetamol within 7 days before start of treatment.
- •9.Surgery or trauma with significant blood loss within the last 3 months before administration of study drug.
- •10.Smokers (negative cotinine test required).
- •11.A positive result of the human immunodeficiency virus (HIV) 1 and 2 test and/or positive Hepatitis B antigen and/or positive Hepatitis C antibody screen.
- •12.A history of alcoholism or drug/chemical abuse, or a positive result in the urine/ drug/ breath alcohol screen, or consumption of more than 14 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits).
- •13.Mental incapacity or language barriers which preclude adequate understanding or cooperation, unwillingness to participate in the trial, known or suspected not to comply with study directives or not to be reliable or trustworthy, or subject who in the opinion of their general practitioner or the Investigator should not participate in the trial.
- •14.Clinically significant abnormal laboratory test results during the screening as judged by the Investigator (one retest within a week is permitted, the last result being conclusive).
- •15.Increased risk of bleeding, e.g. subjects with a history of deep cerebral bleeding or known defects of hemostasis with increased risk of bleeding, as judged by the Investigator.
- •16.Liver enzymes (ALT and AST) more than twice the upper limit of normal.
- •Parts A and B only
- •17.Any history of or presence of clinically significant diseases such as cancer, clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases, other major disorders as judged by the Investigator.
- •18.Supine blood pressure at screening, after resting for 5 min, of > 140 mmHg systolic or > 90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeat measurement on a second screening visit shows values within the range, the subject can be included in the trial).
- •19.Intake of anti-inflammatory drugs, OTC drugs or herbal remedies within 14 days before start of treatment. Steroid therapy other than topical application is not allowed.
- •Part C only
- •20.History of or presence of clinically significant diseases such as cancer, clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases, other major disorders as judged by the Investigator, or significant secondary diabetic complications, such as but not limited to clinically relevant peripheral neuropa;
- •All Parts (A, B and C)
- •1.Employees or personnel affiliated with the Sponsor or Investigator.
- •2.Previous participation (randomisation) in this trial.
- •3.The intake of any investigational drug within one month or five half-lives, whatever is longer, before administration of study drug.
- •4.A history of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator.
- •5.Clinically significant acute illness within 2 weeks before administration of study drug, including severe infections, as judged by the Investigator.
- •6.Abnormal and clinically significant ECG at screening.
- •7.Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening.
- •8.Intake of paracetamol within 7 days before start of treatment.
- •9.Surgery or trauma with significant blood loss within the last 3 months before administration of study drug.
- •10.Smokers (negative cotinine test required).
- •11.A positive result of the human immunodeficiency virus (HIV) 1 and 2 test and/or positive Hepatitis B antigen and/or positive Hepatitis C antibody screen.
- •12.A history of alcoholism or drug/chemical abuse, or a positive result in the urine/ drug/ breath alcohol screen, or consumption of more than 14 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits).
- •13.Mental incapacity or language barriers which preclude adequate understanding or cooperation, unwillingness to participate in the trial, known or suspected not to comply with study directives or not to be reliable or trustworthy, or subject who in the opinion of their general practitioner or the Investigator should not participate in the trial.
- •14.Clinically significant abnormal laboratory test results during the screening as judged by the Investigator (one retest within a week is permitted, the last result being conclusive).
- •15.Increased risk of bleeding, e.g. subjects with a history of deep cerebral bleeding or known defects of hemostasis with increased risk of bleeding, as judged by the Investigator.
- •16.Liver enzymes (ALT and AST) more than twice the upper limit of normal.
- •Parts A and B only
- •17.Any history of or presence of clinically significant diseases such as cancer, clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases, other major disorders as judged by the Investigator.
- •18.Supine blood pressure at screening, after resting for 5 min, of > 140 mmHg systolic or > 90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeat measurement on a second screening visit shows values within the range, the subject can be included in the trial).
- •19.Intake of anti-inflammatory drugs, OTC drugs or herbal remedies within 14 days before start of treatment. Steroid therapy other than topical application is not allowed.
- •Part C only
- •20.History of or presence of clinically significant diseases such as cancer, clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases, other major disorders as judged by the Investigator, or significant secondary diabetic complications, such as but not limited to clinically relevant peripheral neuropa
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