A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants
2014년 9월 29일 업데이트: Janssen Research & Development, LLC
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
연구 개요
상태
완전한
정황
상세 설명
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men.
Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion.
The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center).
During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo.
Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157.
Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level.
The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner.
An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B).
Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo.
Only Caucasian participants will be enrolled in the IV treatment group (group 4).
For each treatment group, blood and urine samples will be taken at various time points during the study.
Each participant will take part in the study for approximately 85 days.
Participant safety will be monitored throughout the study.
연구 유형
중재적
등록 (실제)
40
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Cypress, California, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive
- Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1
Exclusion Criteria:
- Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
- Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
- Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group 1A
100 mg CNTO 3157 or placebo in healthy male Japanese participants
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A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
실험적: Group 1B
100 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
실험적: Group 2A
300 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
실험적: Group 2B
300 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
실험적: Group 3A
600 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
실험적: Group 3B
600 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
실험적: Group 4
300 mg CNTO 3157 in healthy male Caucasian participants
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2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of adverse events
기간: Up to Day 57
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The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
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Up to Day 57
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Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
기간: Up to Day 57
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Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
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Up to Day 57
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Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
기간: Up to Day 57
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Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
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Up to Day 57
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
기간: Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
기간: Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
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Up to Day 57
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 12월 1일
기본 완료 (실제)
2014년 8월 1일
연구 완료 (실제)
2014년 8월 1일
연구 등록 날짜
최초 제출
2013년 12월 6일
QC 기준을 충족하는 최초 제출
2013년 12월 6일
처음 게시됨 (추정)
2013년 12월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 9월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 9월 29일
마지막으로 확인됨
2014년 9월 1일
추가 정보
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