Text Size

Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT01365663
First received: May 18, 2011
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of SPC4955 [ Time Frame: Up to 78 Days ] [ Designated as safety issue: No ]
  • total Cholesterol [ Time Frame: up to 78 days ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) of SPC4955 [ Time Frame: Up to 78 days ] [ Designated as safety issue: No ]
  • LDL [ Time Frame: up to 78 days ] [ Designated as safety issue: No ]
  • HDL [ Time Frame: up to 78 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Santaris Pharma A/S
ClinicalTrials.gov Identifier: NCT01365663     History of Changes
Other Study ID Numbers: SPC4955-901, EudraCT 2010-024363-40
Study First Received: May 18, 2011
Last Updated: January 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 13, 2013