An Open-label, Active-controlled, Parallel and Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- G2GBio, Inc.
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM and SC depot in healthy male Adults. And, It is to evaluate pharmacokinetic characteristics of GB-5001 (donepezil) IM and SC single dose injection vs. active comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit
- •Subject with a body weight of 55 kg or more and a body mass index (BMI) equal to or greater than 18.5 kg/m² but less than 30 kg/m²
- •Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination
- •Subject who has been deemed suitable based on screening test results assessed by the principal investigator
- •Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures
排除标准
- •Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial.
- •Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions.
- •Rhabdomyolysis
- •Seizure, Epilepsy, Fainting
- •peptic ulcer or gastrointestinal hemorrhage
- •Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion
- •Severe physical/organ abnormalities
- •Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus
- •Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial.
- •Medications, including antidepressants, that can induce Rhabdomyolysis
- •Medications with a risk of ulcer development.
- •Potent inhibitors of cytochrome P450 (CYP) enzymes
- •Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors
- •Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access
- •Subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or Subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period
研究组 & 干预措施
GB-5001A
GB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.
干预措施: GB-5001A (Drug)
GB-5001D
GB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.
干预措施: GB-5001D (Drug)
Oral cohort
Aricept® tablet. The cohort is determined through random allocation.
干预措施: Oral cohort (Drug)
结局指标
主要结局
Adverse Events
时间窗: Part A: Cohort A, B : Upto Day 106 / Cohort C : Upto Day 71 / Cohort D : Upto Day 18, Part B: Cohort E, F, M : Upto Day 18 or Day 106
Number of participants with adverse events
Clinical Laboratory tests
时间窗: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99
Incidence of abnormal clinically significant clinical laboratory test results. (Hematology, Blood Chemistry Test, Urine Test, Blood Coagulation Test, Serum Test and Urine Drug Screening Test.) /Day 1 to Day
Vital Signs
时间窗: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99
Incidence of abnormal clinically significant vital signs.(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature)
Physical examination
时间窗: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99
Incidence of abnormal clinically significant Physical examination. (This includes an evaluation of the overall appearance and a review of the physical organ systems through questioning, visual inspection, and palpation.)
Electrocardiograms
时间窗: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99
Incidence of abnormal clinically significant ECG results (Ventricular rate (beats/min), PR interval (msec), QRS (msec), QT (msec), QTc (msec)
次要结局
- Pharmacokinetics (Tmax)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (AUCinf)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (AUClast)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (AUC 0-762)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (CL/F)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (Vd/F)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (t1/2)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (Tlag)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)
- Pharmacokinetics (Cmax)(Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99)