Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect efficacy, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])
- Conditions
- Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])MedDRA version: 20.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000022953Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-002106-13-SE
- Lead Sponsor
- Athera Biotechnologies AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method