Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).

Study Overview
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Brief Summary
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This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.

Official Title
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Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: DKF-310
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 19 to 50 years Body weight 55 to 90 kg and BMI 18.0 to 27.0 Voluntarily signed the informed consent form Eligible according to the screening test results Available to follow up after drop-out Exclusion Criteria: Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases Hypersensitivity to donepezil, piperidine derivatives and other drugs SBP <100 mmHg or >150 mmHg, or DBP <60 mmHg or >100 mmHg Skin and muscle disorders or history of surgery at the injection site AST or ALT >1.5xULN; QT/QTcB interval >450 ms History or positive result of drug abuse Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week Participated in other clinical trials within 3 months Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month Alcohol consumption >21 units/week Smoked >10 cigarettes/day within 3 months Caffeine-containing foods Not eligible due to other reasons at the investigator's discretion

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donepezil 35 mg<br>Donepezil 35 mg or placebo | Drug: DKF-310<br> <br> * Other names: Donepezil;Drug: Placebo<br> <br> |
| Experimental: Donepezil 70 mg<br>Donepezil 70 mg or placebo | Drug: DKF-310<br> <br> * Other names: Donepezil;Drug: Placebo<br> <br> |
| Experimental: Donepezil140 mg<br>Donepezil 140 mg or placebo | Drug: DKF-310<br> <br> * Other names: Donepezil;Drug: Placebo<br> <br> |
| Experimental: Donepezil 210 mg<br>Donepezil 210 mg or placebo | Drug: DKF-310<br> <br> * Other names: Donepezil;Drug: Placebo<br> <br> |
| Experimental: Donepezil 280 mg<br>Donepezil 280 mg or placebo | Drug: DKF-310<br> <br> * Other names: Donepezil;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h | 1056h | 
| Cmax | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h | 1056h |