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.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Tokyo, 일본
- Sanofi-Aventis Administrative Office
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cohort 1
Alirocumab dose 1 versus placebo
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Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
다른 이름들:
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous |
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실험적: Cohort 2
Alirocumab dose 2 versus placebo
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Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
다른 이름들:
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous |
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실험적: Cohort 3
Alirocumab dose 3 versus placebo
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Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
다른 이름들:
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous |
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실험적: Cohort 4
Alirocumab dose 4 versus placebo
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Pharmaceutical form: solution Route of administration: subcutaneous
다른 이름들:
Pharmaceutical form: solution Route of administration: subcutaneous |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of participants with Adverse Events
기간: 106 days
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106 days
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.
기간: 106 days
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106 days
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Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.
기간: 106 days
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106 days
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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.
기간: 106 days
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106 days
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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Alirocumab (Lyophilized formulation)에 대한 임상 시험
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Boehringer Ingelheim모병
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University of Roehampton모집하지 않고 적극적으로
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China Academy of Chinese Medical SciencesNational Natural Science Foundation of China모병
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EMD Serono완전한
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Merck KGaA, Darmstadt, Germany완전한다발성 경화증, 재발 완화