Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults
This study is a open and multiple dose escalation phase I clinical study, aiming to evaluate the pharmacokinetic characteristics and safety of Benaglutide Injection in overweight/obese adults after multiple subcutaneous injections.
This study will enroll 16 overweight/obese adults, both male and female. The trial was divided into two batches, including 4 subjects who completed all dosing, safety assessment and telephone follow-up, and the remaining 12 subjects who were enrolled for the trial. All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
Subjects will be screened at D-14-D-2, and eligible subjects D-2 will be admitted to the phase I clinical trial ward at D-2. D-1 Blank blood samples were collected at different time points before and after breakfast for PK test baseline correction. D1 began by subcutaneously injecting different doses of benaglutide injection 5 minutes before the daily three meals, collecting biological samples at different time points after the first administration of D6, D7, D11, D12 and D16 to evaluate the pharmacokinetic characteristics of Benaglutide. Subjects will be discharged after all samples are collected and safety assessed at D17. Telephone follow-up was performed on the 7th day after discharge (D24±2) to further observe safety.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Shandong
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Qingdao, Shandong, 중국, 266003
- The Affiliated Hospital Of Qingdao University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female aged between 18 and 70 years old (including the critical value).
BMI meets the following requirements (a or b):
- BMI>28 kg/m2;
- BMI>24 kg/m2 with at least one of the following symptoms:
Vigorous appetite, hunger before meals unbearable, each meal into more food. Combined with hyperglycemia, hypertension, dyslipidemia, fatty liver in one or several.
Combined with weight-bearing joint pain. Obesity causes dyspnea or obstructive sleep apnea syndrome.
- The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG.
- The subjects have no family planning within 3 months and could select contraceptive method.
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Exclusion Criteria:
- Patients with type 1 diabetes or type 2 diabetes with a clear diagnosis;
- Fasting intravenous blood glucose ≥7 mmol/L or 75g during screening. Oral glucose tolerance test (OGTT) two hours after glucose load;
- Fasting venous blood glucose <2.8 mmol/L at screening, and/or those with a history of hypoglycemia;
- Those who complained of a weight change of >5% within 3 months before screening;
- Have used weight loss drugs or hypoglycemic drugs that may affect body weight within 4 weeks before screening;
- Drugs used within 4 weeks before screening that may cause significant weight gain: including systemic glucocorticoid therapy (lasting more than 1 week); tricyclic antidepressants; antipsychotic or antidepressant drugs; may interfere with blood sugar regulation Functional medicine; all proprietary Chinese medicines and Chinese herbal medicines;
- Those who have a clear history of malignant tumors,
- People with Cushing's syndrome, hypothyroidism, polycystic ovary disease or other genetic endocrine diseases or medical history;
- Those who have a history of bariatric surgery;
- Have a history of multiple endocrine tumors or a family history; have a history of medullary thyroid carcinoma or other tumors, a family history;
- History of acute and chronic pancreatitis;
- Moderate to severe gastrointestinal diseases with additional gastrointestinal motility disorders or obstructive enteropathy;
- Have a clear history of mental illness
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Benaglutide Injection
All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing.
The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
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All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing.
The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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혈장 농도 대 시간 곡선 아래 면적(AUC)0-t
기간: 80일
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혈장 농도 대 시간 곡선 아래 면적 평가(AUC)0-t
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80일
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Peak Plasma Concentration (Cmax)
기간: 80 days
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Evaluation of Peak Plasma Concentration (Cmax)
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80 days
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Area under the plasma concentration versus time curve (AUC)0-∞
기간: 80 days
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Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
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80 days
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elimination half-life time(T1/2)
기간: 80 days
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Evaluation of elimination half-life time(T1/2)
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80 days
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The total clearance(CL)
기간: 80 days
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Evaluation of the total clearance(CL)
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80 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Treatment Adverse Events
기간: 80 days
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Collection of adverse events
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80 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Benaglutide Injection에 대한 임상 시험
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China Academy of Chinese Medical SciencesNational Natural Science Foundation of China모병
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Shanghai Junshi Bioscience Co., Ltd.모집하지 않고 적극적으로
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Shanghai University of Traditional Chinese Medicine알려지지 않은
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North American Institute for Continuing Medical...완전한
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Bispebjerg Hospital완전한
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Samsung Medical Center빼는
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...PPD모집하지 않고 적극적으로