Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: SPC4955; Drug: Saline 0.9%

• Registration Number: NCT01365663
• Lead Sponsor: Santaris Pharma A/S

Brief Summary

The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	SPC4955	0.25 mg/kg in Healthy Subjects
Cohort 3	SPC4955	1.0 mg/kg in Healthy Subjects
Saline 0.9%	Saline 0.9%	-
Cohort 4	SPC4955	1.5 mg/kg in Healthy Subjects
Cohort 5	SPC4955	2.0 mg/kg in Healthy Subjects
Cohort 2	SPC4955	0.5 mg/kg in Healthy Subjects

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing adverse events	up to 78 days

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of SPC4955	Up to 78 Days
Area under the plasma concentration versus time curve (AUC) of SPC4955	Up to 78 days
LDL	up to 78 days
total Cholesterol	up to 78 days
HDL	up to 78 days

Trial Locations

Locations (1)

Nuvisan GmbH; 🇩🇪 Neu-Ulm, Germany