Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

NCT01365663 | Completed Phase 1

• 2 other identifiers: SPC4955-901EudraCT 2010-024363-40
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; LDL; HDL; apoB; hyperlipidemia; LNA-oligonucleotide

Outcome Measures

Primary Outcomes (1)

• Number of subjects experiencing adverse events

  up to 78 days

Secondary Outcomes (5)

• Peak Plasma Concentration (Cmax) of SPC4955

  Up to 78 Days

• total Cholesterol

  up to 78 days

• Area under the plasma concentration versus time curve (AUC) of SPC4955

  Up to 78 days

• LDL

  up to 78 days

• HDL

  up to 78 days

Study Arms (6)

Cohort 1

EXPERIMENTAL

0.25 mg/kg in Healthy Subjects

Drug: SPC4955

Cohort 2

EXPERIMENTAL

0.5 mg/kg in Healthy Subjects

Drug: SPC4955

Cohort 3

EXPERIMENTAL

1.0 mg/kg in Healthy Subjects

Drug: SPC4955

Cohort 4

EXPERIMENTAL

1.5 mg/kg in Healthy Subjects

Drug: SPC4955

Cohort 5

EXPERIMENTAL

2.0 mg/kg in Healthy Subjects

Drug: SPC4955

Saline 0.9%

PLACEBO COMPARATOR

Drug: Saline 0.9%

Interventions

SPC4955 DRUG

3 Weekly SC injections

Cohort 1

Saline 0.9% DRUG

3 Weekly SC injections

Saline 0.9%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects, age 18-65 years, inclusive.
• BMI 18-33 kg/m2
• 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

You may not qualify if:

• 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. 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
• Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
• Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
• 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.
• 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.

Sponsors & Collaborators

• Santaris Pharma A/S: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Werner Feuerer, Dr. med.

  Nuvisan GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

DE (1)