- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01448317
Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects
Primary Objective:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Secondary Objectives:
- To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
- To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the immunogenicity of a single SC dose of alirocumab.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Tokyo, Japan
- Sanofi-Aventis Administrative Office
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy male subject, between 20 and 65 years inclusive.
- Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
- Serum LDL-C levels >100 mg/dL
Exclusion Criteria:
- Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
- History or presence of drug or alcohol abuse
- Smoking more than 5 cigarettes or equivalent in any 24 hour period.
- Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
- Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
- Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
- Presence or history of drug hypersensitivity
- Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
- Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Cohort 1
Alirocumab dose 1 versus placebo
|
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Andre navne:
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous |
Eksperimentel: Cohort 2
Alirocumab dose 2 versus placebo
|
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Andre navne:
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous |
Eksperimentel: Cohort 3
Alirocumab dose 3 versus placebo
|
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Andre navne:
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous |
Eksperimentel: Cohort 4
Alirocumab dose 4 versus placebo
|
Pharmaceutical form: solution Route of administration: subcutaneous
Andre navne:
Pharmaceutical form: solution Route of administration: subcutaneous |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of participants with Adverse Events
Tidsramme: 106 days
|
106 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.
Tidsramme: 106 days
|
106 days
|
Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.
Tidsramme: 106 days
|
106 days
|
Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit.
Tidsramme: 106 days
|
106 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TDU12190
- U1111-1118-1213 (Anden identifikator: UTN)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Alirocumab (Lyophilized formulation)
-
China Academy of Chinese Medical SciencesNational Natural Science Foundation of ChinaRekrutteringAkut hjertesvigt | Kinesisk medicin | Komplementær medicinKina
-
Fundación Hipercolesterolemia FamiliarAfsluttetFamiliær hyperkolesterolæmiSpanien
-
Westside Medical Associates of Los AngelesRegeneron Pharmaceuticals; University of WashingtonUkendtÅreforkalkning | HyperlipidæmiForenede Stater
-
Population Health Research InstituteAfsluttetST Elevation Myokardieinfarkt | Dyslipidæmi | Hyperkolesterolæmi | Hyperlipidæmi | Akut koronarsyndrom | Lægemidlers fysiologiske virkningerCanada
-
Shanghai Tong Ren HospitalChina Cardiovascular AssociationRekrutteringAkut myokardieinfarktKina
-
Regeneron PharmaceuticalsSanofiAfsluttetHyperkolesterolæmiForenede Stater, Bulgarien, Chile, Estland, Japan, Mexico, Den Russiske Føderation, Sydafrika, Ukraine
-
University of VirginiaNorthwestern UniversityAfsluttetPerifer arteriel sygdomForenede Stater
-
Regeneron PharmaceuticalsSanofiAfsluttetHeterozygot familiær hyperkolesterolæmi | Ikke-familiær hyperkolesterolæmiForenede Stater, Bulgarien, Estland, Den Russiske Føderation, Sydafrika, Ukraine
-
Washington University School of MedicineAfsluttet
-
University Hospital Inselspital, BerneRegeneron PharmaceuticalsAfsluttetKoronar Cirkulation | Atherom; Myokardie | KoronarkarDanmark, Schweiz, Østrig, Holland