EUCTR2017-002106-13-SE进行中（未招募）1 期
Double-blind, randomised, placebo-controlled, multicentre, Phase IIa study to investigate the effect of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a])
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1.Provision of a signed written informed consent
- •2.Lp(a) above 50 mg/dL at screening
- •3.Male or female, = 50 years of age at screening
- •4.Weight of at least 63 kg and maximum 125 kg at screening (dose = 2-4 mg/kg body weight)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the result or the subject’s ability to participate in the study
- •2.Illness (including common colds) for the last 4 weeks before Visit 3 and Visit 4
- •3.Medical history of myocardial infarction (MI) or stroke within 12 months of screening
- •4.Ongoing or paroxysmal atrial fibrillation
- •5.Clinically overt heart failure
- •6.Hypertension defined as =180/100 mmHg
- •7.Diabetes mellitus
- •8.Ongoing treatment with statins or PCSK9 inhibitor
- •Except when:
- •Statin is prescribed for primary prevention and Lp(a) >50 mg/dl and LDLc >100 mg/dL (2.5 mmol/L)
- •Statin and/or PCSK9, or other lipid lowering medication, are prescribed for secondary prevention, and Lp(a) >50 mg/dL
- •9.Systemic autoimmune diseases requiring treatment
- •10.Cancer, excluding basal cell carcinoma, within the last five years
- •11.Medical PET, SPECT, abdominal or thoracic CT examination during the previous 12 months’ time period
- •12.Conditions contraindicating MRI such as, but not limited to, claustrophobia, having a history of brain or heart surgery and pacemaker implantation, permanent make-up, past or present occupation as metalworker or welder. Having metallic implants that cannot be declared safe under the employed MRI scanning conditions, or which will significantly degrade MRI scan quality.
- •13.Positive HIV or hepatitis test
- •14.Clinically significant abnormal findings in haematology or clinical chemistry at screening or any value = 3 times the upper limit of normal haematology or clinical chemistry at screening
- •15.The subject is unable to understand the written and verbal instructions
- •16.Pregnant or breast feeding women. A negative urine pregnancy test must be demonstrated in females at screening. The females must be of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 month of amenorrhea (in questionable cases a blood sample with simultaneous determination of follicle stimulating hormone 25 150 IE/L and estradiol <200 pmol/L is confirmatory). The male subjects must agree to use condom in combination with use of contraceptive methods with failure rate of <1% to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after last dosing of the IMP.
- •17.History or current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study
- •18.Subjects who have participated in any other clinical study that included drug treatment within 3 months of the administration of investigational product in this study
- •19.Subjects who have received any type of vaccination within 21 days before dosing or who anticipate the need for vaccination before the end of the study
- •20.Plasma donation within one month of screening or any blood donation/blood loss >450 mL during 3 months prior to screening
- •21.Subjects who have planned any scheduled invasive treatment/surgical procedure during the whole study
- •22.Investigator considers subject unlikely to comply with study procedures, restrictions and requirements
- •23.History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
- •24.Recent (<1 month prior to screening) or current treatment with medications that may have a si
研究者
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