Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, LDL, HDL, apoB, hyperlipidemia, LNA-oligonucleotide
Brief summary
The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.
Interventions
DRUGSPC4955
3 Weekly SC injections
DRUGSaline 0.9%
3 Weekly SC injections
Sponsors
Santaris Pharma A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female subjects, age 18-65 years, inclusive. 2. BMI 18-33 kg/m2 3. Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met: * LDL-C ≥3.24 mmol/L (≥125 mg/dL) * Triglycerides (fasted) \<2.7mmol/L (\<239 mg/dL) * ALT within normal limits
Exclusion criteria
1. Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential. 2. History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled 3. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection 4. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study. 5. Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies. 6. Positive results on the following Screening laboratory tests: urine pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects experiencing adverse events | up to 78 days |
Secondary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of SPC4955 | Up to 78 Days |
| total Cholesterol | up to 78 days |
| Area under the plasma concentration versus time curve (AUC) of SPC4955 | Up to 78 days |
| LDL | up to 78 days |
| HDL | up to 78 days |
Countries
Germany
Outcome results
None listed