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

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

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

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