A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC5001 Administered to Healthy Subjects and Subjects with Familial Hypercholesterolemia (FH)
Completed
- Conditions
- familial hypercholesterolemiaIncreased blood cholesterol level1002742410013317
- Registration Number
- NL-OMON36203
- Lead Sponsor
- Santaris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
Age: 18-65 years (healthy subjects)
Age: 18-45 years (FH subjects)
BMI: 18-33 kg/m2
LDL >= 2.59 mmol/L (>=100 mg/dL)
Triglycerides (fasted) < 4.5 mmol/L (<398 mg/dL)
ALT within normal limits (healthy subjects)
ALT <= 2x ULN (FH subjects)
Subjects with FH without a history of cardiovascular disease, hypertension or diabetes mellitus can be enrolled in cohort 5.
Exclusion Criteria
Any uncontrolled or active major systemic disease.
History or presence of malignancy in the past year.
Active acute or chronic infection.
Clinically significant illness within 30 days prior to the planned first drug administration.
See protocol for other criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety will be evaluated from reported adverse events, scheduled physical<br /><br>examinations, hepatic ultrasounds, vital signs, 12-lead ECGs,<br /><br>and clinical laboratory test results.</p><br>
- Secondary Outcome Measures
Name Time Method