A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).
This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).
연구 유형
연구 유형
등록 (예상)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Hua Fang li, MD
- 전화번호: 021-34773107
- 이메일: lhlh_5@163.com
연구 연락처 백업
- 이름: Li Yan, Research Doctor
- 전화번호: 021-34773107
- 이메일: lhlh_5@163.com
연구 장소
-
-
Shanghai
-
Shanghai, Shanghai, 중국, 200030
- 모병
- Shanghai Mental Health Center
-
연락하다:
- Hua Fang li, MD
- 전화번호: 021-34773107
- 이메일: lhlh_5@163.com
-
연락하다:
- Li Yan, Research Doctor
- 전화번호: 021-34773107
- 이메일: lhlh_5@163.com
-
수석 연구원:
- Hua Fang Li, MD
-
부수사관:
- Li Yan, Research Doctor
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male/female subjects are 18<age ≤45 years of age when signing the informed consent.
- Male Subjects with body weight of ≥50.0kg ,and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination.
- After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
- Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study.
Exclusion Criteria:
- The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
- There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
- Subjects with past history of allergy to drugs or allergic disease.
- Subjects with currently or past history of mental disorders and brain functional disorders.
- According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
- Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
- Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
- Average amount of daily smoking>5 cigarettes at screening 3 months prior.
- Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
- Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
- Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
- Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
- Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
- Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit.
- Subjects who participated in any clinical trial within 3 months before medication.
- Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
- Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
- Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
- Subjects who directly related to this clinical trial.
- Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
다른 이름들:
|
|
실험적: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
다른 이름들:
|
|
실험적: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
다른 이름들:
|
|
실험적: 10mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
다른 이름들:
|
|
실험적: 18mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
다른 이름들:
|
|
실험적: 24mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of AEs
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Incidence of Adverse Events
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cmax
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Maximum (peak) observed drug serum concentration
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
AUC0-t
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
AUC0-∞
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
%AUCex
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Extrapolation percentage of AUC0-∞
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
Tmax
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Time of occurrence of Cmax
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
T1/2
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
Vd
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Apparent volume of distribution
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
CL
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Clearance
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
|
λz
기간: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Elimination rate constant
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Hua Fang li, MD, Shanghai Mental Health Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (예상)
기본 완료
연구 완료 (예상)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NH101-11
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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