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

May 18, 2011
January 26, 2012
May 2011
October 2011   (final data collection date for primary outcome measure)
Number of subjects experiencing adverse events [ Time Frame: up to 78 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01365663 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Multiple Ascending Dose Study of SPC4955 in Healthy Subjects
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: SPC4955
    3 Weekly SC injections
  • Drug: Saline 0.9%
    3 Weekly SC injections
  • Experimental: Cohort 1
    0.25 mg/kg in Healthy Subjects
    Intervention: Drug: SPC4955
  • Experimental: Cohort 2
    0.5 mg/kg in Healthy Subjects
    Intervention: Drug: SPC4955
  • Experimental: Cohort 3
    1.0 mg/kg in Healthy Subjects
    Intervention: Drug: SPC4955
  • Experimental: Cohort 4
    1.5 mg/kg in Healthy Subjects
    Intervention: Drug: SPC4955
  • Experimental: Cohort 5
    2.0 mg/kg in Healthy Subjects
    Intervention: Drug: SPC4955
  • Placebo Comparator: Saline 0.9%
    Intervention: Drug: Saline 0.9%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01365663
SPC4955-901, EudraCT 2010-024363-40
No
Santaris Pharma A/S
Santaris Pharma A/S
Not Provided
Principal Investigator: Werner Feuerer, Dr. med. Nuvisan GmbH
Santaris Pharma A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP