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 hypercholesterolemia; Increased blood cholesterol level; 10027424; 10013317

• Registration Number: NL-OMON36203
• Lead Sponsor: Santaris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-29

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