EUCTR2017-002106-13-SE
Active, not recruiting
Phase 1
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])
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])
- Sponsor
- Athera Biotechnologies AB
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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