Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5207; Drug: Donepezil Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT04013477

DA5207_ADK_Ia

Details and patient eligibility

About

A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults

Enrollment: 40 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health Male Volunteers (Age : 19~55 years)
• Body Weight : Male≥55kg, Female≥50kg
• 18.5≤BMI<25.0

Exclusion criteria

• Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
• Allergy or Drug hypersensitivity
• Clinically significant Medical History
• AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m²
• Heavy alcohol intake (more than 210g/week)
• Heavy smoker (more than 10 cigarettes/day)
• Heavy caffeine intake

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Cohort1

Experimental group

Description:

drug : DA-5207 80mg/40cm² placebo : 40cm²

Treatment:

Drug: DA-5207

Cohort2

Experimental group

Description:

drug : DA-5207 120mg/60cm² placebo : 60cm²

Treatment:

Drug: DA-5207

Cohort3

Experimental group

Description:

drug : DA-5207 160mg/80cm² placebo : 80cm²

Treatment:

Drug: DA-5207

Cohort4

Active Comparator group

Description:

drug : Aricept

Treatment:

Drug: Donepezil Hydrochloride