Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

Hypercholesterolemia Clinical Trial

Official title:

A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC4955 Administered to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365663
• Other study ID #: SPC4955-901
• Secondary ID: EudraCT 2010-024
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2011
• Last updated: January 26, 2012
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• SPC4955
3 Weekly SC injections
• SPC4955
3 Weekly SC injections
• SPC4955
3 Weekly SC injections
• SPC4955
3 Weekly SC injections
• SPC4955
3 Weekly SC injections
• Saline 0.9%
3 Weekly SC injections

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing adverse events		up to 78 days	Yes
Secondary	Peak Plasma Concentration (Cmax) of SPC4955		Up to 78 Days	No
Secondary	total Cholesterol		up to 78 days	No
Secondary	Area under the plasma concentration versus time curve (AUC) of SPC4955		Up to 78 days	No
Secondary	LDL		up to 78 days	No
Secondary	HDL		up to 78 days	No