Clinical trial • Phase IV • Endocrinology
EVOLOCUMAB for Healthy volunteers
Phase IV trial of EVOLOCUMAB for Healthy volunteers. 8 participants.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 31-01-2024
- First CTIS Authorization Date
- 12-04-2024
Trial design
Phase IV trial across 1 site in Sweden.
- Target Sample Size
- 8
Eligibility
Recruits 8 adults.
- Pregnancy Exclusion
- Pregnancy
Inclusion criteria
- {"criterion_text":"- 18-64 year old\n- Male"}
Exclusion criteria
- {"criterion_text":"- Cardiovascular disease\n- Any chronic medication use\n- Steroid treatment for the last six months or HRT\n- Coagulopathy\n- Musculoskeletal or neurologic disease\n- Inclusion in any other concurrent medical research study\n- Cerebrovascular disease (e.g. stroke, prior aneurysm)\n- Pulmonary disease (e.g. pulmonary hypertension, COPD)\n- Metabolic disease (incl. but not limited to Cushing disease, Diabetes)\n- Renal disease (by CKD criteria)\n- Active inflammatory bowel syndrome\n- Cancer\n- Pregnancy\n- Smoker"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Changes in the measured parameters of cholesterol and bile acid metabolism","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 8
- Recruitment Window Months
- 11
- Consent Approach
- Informed consent will be obtained from adult participants (18-64 years); subject information and informed consent form documents are listed in the trial documents. No details on assent, age-specific documents or languages are provided in the available record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 8
Sweden
- Earliest CTIS Part Ii Submission Date
- 31-01-2024
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 404
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Endocrinology Huddinge sjukhus
- Principal Investigator Name
- Mats Eriksson
- Principal Investigator Email
- mats.eriksson@ki.se
- Contact Person Name
- Mats Eriksson
- Contact Person Email
- mats.eriksson@ki.se
- Number Of Participants
- 8
Sponsor
Primary sponsor
- Full Name
- Karolinska University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Third parties
- {"country":"","full_name":"Region Stockholm/ALF","duties_or_roles":"Monetary support","organisation_type":""}
- {"country":"","full_name":"Hjärt-Lungfonden","duties_or_roles":"Monetary support","organisation_type":""}
- {"country":"","full_name":"Amgen AB","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- EVOLOCUMAB
- Active Substance
- EVOLOCUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Already EMA approved
- Maximum Dose
- 1 U unit(s) (max daily); 2 U unit(s) (max total)
- Investigational Product Name
- ATORVASTATIN
- Active Substance
- ATORVASTATIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Already EMA approved
- Maximum Dose
- 40 mg (max daily)
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