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Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT01350960
First received: May 5, 2011
Last updated: November 21, 2011
Last verified: November 2011

May 5, 2011
November 21, 2011
May 2011
October 2011   (final data collection date for primary outcome measure)
Safety and Tolerability [ Time Frame: Regularly over 78 days ] [ Designated as safety issue: Yes ]
Safety evaluation will assess adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring
Same as current
Complete list of historical versions of study NCT01350960 on ClinicalTrials.gov Archive Site
  • Peak Plasma Concentration (Cmax) of SPC5001 [ Time Frame: up to 78 days ] [ Designated as safety issue: No ]
  • Lipid lowering effect [ Time Frame: Through out the study ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) of SPC5001 [ Time Frame: up to 78 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH
A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC5001 Administered to Healthy Subjects and Subjects With Familial Hypercholesterolemia (FH)

The purpose is to study Safety and Tolerability.

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: SPC5001
    3 weekly SC injections
  • Drug: Saline 0.9%
    3 weekly SC injections
  • Placebo Comparator: saline 0.9%
    Intervention: Drug: Saline 0.9%
  • Experimental: Cohort 1
    0.5 mg/kg in Healthy Subjects
    Intervention: Drug: SPC5001
  • Experimental: Cohort 2
    1.5 mg/kg in Healthy subjects
    Intervention: Drug: SPC5001
  • Experimental: Cohort 3
    5.0 mg/kg in Healthy subjects
    Intervention: Drug: SPC5001
  • Experimental: Cohort 4
    10 mg/kg in Healthy subjects
    Intervention: Drug: SPC5001
  • Experimental: Cohort 5
    TBD mg/kg in FH subjects
    Intervention: Drug: SPC5001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
November 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy male or female subjects and subjects with heterozygous Familial Hypercholesterolemia

    • Healthy male or female subjects, age 18 to 65 years, inclusive will be enrolled in Cohorts 1 through 4.
    • In Cohort 5, male or female subjects with heterozygous Familial Hypercholesterolemia, confirmed through genetic testing, without a history of cardiovascular disease (e.g. coronary artery, peripheral artery or cerebrovascular disease), hypertension or diabetes mellitus age 18-45 years, inclusive, will be enrolled.
  2. BMI of 18-33 kg/m2
  3. Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:

    • LDL ≥.3.24 mmol/L (≥ 100 mg/dL)
    • Triglycerides (fasted) < 4.5 mmol/L (< 398 mg/dL)
    • ALT within normal limits for healthy subjects and ALT < 2 x ULN for FH subjects

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

    - History or presence of malignancy within the past year is an exclusion criterion. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.

  2. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
  3. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study. For the FH subjects statin therapy (and other lipid lowering therapies) will be prohibited within 4 weeks prior to the first study drug administration.
  4. 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. An exception can be made for medication or supplements that in the opinion of both the investigator and the Sponsor do not complicate or compromise the study or interfere with the study objectives.
  5. Positive results on the following Screening laboratory tests: urine or serum 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
Netherlands
 
NCT01350960
SPC5001-901, EudraCT 2011-000489-36
Not Provided
Santaris Pharma A/S
Santaris Pharma A/S
Not Provided
Principal Investigator: Koos Burggraaf, MD PhD Centre for Human Drug Research (CHDR)
Santaris Pharma A/S
November 2011

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