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)
Sponsor study identifier
Secondary identifiers
interventional
24
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
November 2011
Actual (reported)The purpose is to study Safety and Tolerability.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 5, 2011
Actual (reported)May 10, 2011
Actual (reported)October 2011
Actual (reported)November 2011
Actual (reported)Safety and Tolerability
Safety evaluation will assess adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring
Regularly over 78 days
Peak Plasma Concentration (Cmax) of SPC5001
up to 78 days
Lipid lowering effect
Through out the study
Area under the plasma concentration versus time curve (AUC) of SPC5001
up to 78 days
0.5 mg/kg in Healthy Subjects
1.5 mg/kg in Healthy subjects
3 weekly SC injections
3 weekly SC injections
Centre for Huma Drug Research (CHDR)
Leiden, 2333, Netherlands
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.
Koos Burggraaf, MD PhD
Centre for Human Drug Research (CHDR)
24 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2011
First Posted
May 10, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects
5.0 mg/kg in Healthy subjects
10 mg/kg in Healthy subjects
TBD mg/kg in FH subjects
3 weekly SC injections
3 weekly SC injections
3 weekly SC injections
3 weekly SC injections
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
November 22, 2011
Record last verified: 2011-11
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Source: ClinicalTrials.gov.
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