Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

January 26, 2012 updated by: Santaris Pharma A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neu-Ulm, Germany, 89231
        • Nuvisan GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
0.25 mg/kg in Healthy Subjects
Drug: SPC4955
3 Weekly SC injections
Experimental: Cohort 2
0.5 mg/kg in Healthy Subjects
Drug: SPC4955
3 Weekly SC injections
Experimental: Cohort 3
1.0 mg/kg in Healthy Subjects
Drug: SPC4955
3 Weekly SC injections
Experimental: Cohort 4
1.5 mg/kg in Healthy Subjects
Drug: SPC4955
3 Weekly SC injections
Experimental: Cohort 5
2.0 mg/kg in Healthy Subjects
Drug: SPC4955
3 Weekly SC injections
Placebo Comparator: Saline 0.9%
Drug: Saline 0.9%
3 Weekly SC injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects experiencing adverse events
Time Frame: up to 78 days
up to 78 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santaris Pharma A/S

Investigators

  • Principal Investigator: Werner Feuerer, Dr. med., Nuvisan GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC4955-901
  • EudraCT 2010-024363-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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