Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH
NCT ID: NCT01350960
Last Updated: 2011-11-22
Study Results
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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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2011-05-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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saline 0.9%
Saline 0.9%
3 weekly SC injections
Cohort 1
0.5 mg/kg in Healthy Subjects
SPC5001
3 weekly SC injections
Cohort 2
1.5 mg/kg in Healthy subjects
SPC5001
3 weekly SC injections
Cohort 3
5.0 mg/kg in Healthy subjects
SPC5001
3 weekly SC injections
Cohort 4
10 mg/kg in Healthy subjects
SPC5001
3 weekly SC injections
Cohort 5
TBD mg/kg in FH subjects
SPC5001
3 weekly SC injections
Interventions
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SPC5001
3 weekly SC injections
Saline 0.9%
3 weekly SC injections
SPC5001
3 weekly SC injections
SPC5001
3 weekly SC injections
SPC5001
3 weekly SC injections
SPC5001
3 weekly SC injections
Eligibility Criteria
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Inclusion Criteria
* 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
\- 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Santaris Pharma A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Koos Burggraaf, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Human Drug Research (CHDR)
Locations
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Centre for Huma Drug Research (CHDR)
Leiden, , Netherlands
Countries
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References
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van Poelgeest EP, Hodges MR, Moerland M, Tessier Y, Levin AA, Persson R, Lindholm MW, Dumong Erichsen K, Orum H, Cohen AF, Burggraaf J. Antisense-mediated reduction of proprotein convertase subtilisin/kexin type 9 (PCSK9): a first-in-human randomized, placebo-controlled trial. Br J Clin Pharmacol. 2015 Dec;80(6):1350-61. doi: 10.1111/bcp.12738. Epub 2015 Oct 24.
Other Identifiers
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EudraCT 2011-000489-36
Identifier Type: -
Identifier Source: secondary_id
SPC5001-901
Identifier Type: -
Identifier Source: org_study_id