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Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

NCT ID: NCT01365663

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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Hypercholesterolemia LDL HDL apoB hyperlipidemia LNA-oligonucleotide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

0.25 mg/kg in Healthy Subjects

Group Type EXPERIMENTAL

SPC4955

Intervention Type DRUG

3 Weekly SC injections

Cohort 2

0.5 mg/kg in Healthy Subjects

Group Type EXPERIMENTAL

SPC4955

Intervention Type DRUG

3 Weekly SC injections

Cohort 3

1.0 mg/kg in Healthy Subjects

Group Type EXPERIMENTAL

SPC4955

Intervention Type DRUG

3 Weekly SC injections

Cohort 4

1.5 mg/kg in Healthy Subjects

Group Type EXPERIMENTAL

SPC4955

Intervention Type DRUG

3 Weekly SC injections

Cohort 5

2.0 mg/kg in Healthy Subjects

Group Type EXPERIMENTAL

SPC4955

Intervention Type DRUG

3 Weekly SC injections

Saline 0.9%

Group Type PLACEBO_COMPARATOR

Saline 0.9%

Intervention Type DRUG

3 Weekly SC injections

Interventions

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SPC4955

3 Weekly SC injections

Intervention Type DRUG

SPC4955

3 Weekly SC injections

Intervention Type DRUG

SPC4955

3 Weekly SC injections

Intervention Type DRUG

SPC4955

3 Weekly SC injections

Intervention Type DRUG

SPC4955

3 Weekly SC injections

Intervention Type DRUG

Saline 0.9%

3 Weekly SC injections

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Santaris Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Feuerer, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Nuvisan GmbH

Locations

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Nuvisan GmbH

Neu-Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT 2010-024363-40

Identifier Type: -

Identifier Source: secondary_id

SPC4955-901

Identifier Type: -

Identifier Source: org_study_id