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Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365663
First Posted: June 3, 2011
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santaris Pharma A/S
  Purpose
The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.

Condition Intervention Phase
Hypercholesterolemia Drug: SPC4955 Drug: Saline 0.9% Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Santaris Pharma A/S:

Primary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: up to 78 days ]

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

Enrollment: 18
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365663


Locations
Germany
Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Santaris Pharma A/S
Investigators
Principal Investigator: Werner Feuerer, Dr. med. Nuvisan GmbH
  More Information

Responsible Party: Santaris Pharma A/S
ClinicalTrials.gov Identifier: NCT01365663     History of Changes
Other Study ID Numbers: SPC4955-901
EudraCT 2010-024363-40
First Submitted: May 18, 2011
First Posted: June 3, 2011
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Santaris Pharma A/S:
Hypercholesterolemia
LDL
HDL
apoB
hyperlipidemia
LNA-oligonucleotide

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases