The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A
Alopecia
About this trial
This is an interventional treatment trial for Alopecia
Eligibility Criteria
Inclusion Criteria:
- Those who aged between 19 to 50
(Part 1) Those who are diagnosed to androgenic alopecia and meet criteria BASP grade
- M2~M3 or C2~C3 grade with V1~V3 or F1~F3
- M1 or C1 grade with V2~V3 or F2~F3
(Part 1) Those who consent to the condition write below
- Scalp tattoo & to cutting hair for hair evaluation
- Maintaining hair style & color
- (Part 2) Those who are healthy male (Regardless of alopecia)
- Those who has body weight ≥ 55kg
Those who has calculated body mass index(BMI) of 18.5 ≤ ~ < 27.0 kg/m2
- Body Mass Index, kg/m2= Body weight(kg)/[Height(m)2]
- Those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product
- Those who understanding the detailed description of this clinical trial and voluntarily decide to participate
Exclusion Criteria:
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Hemato-oncology disorder, Cardiovascular disorder or Psychical disorder
(Part 1) Those who meets the conditions write below
- alopecia areata, telogen alopecia
- Those who has psoriasis or folliculitis or scar on hair evaluation area
- Those who has experience of platelet-enriched plasma treatment to scarp within 24 weeks before the first administration of investigational product
- Those who has experience of light or laser treatment to scarp within 12 weeks before the first administration of investigational product
- Those who has experience of prophylaxis or medication of hair loss within 14 days before the first administration of investigational product
- Those who take dutasteride or finasteride within 6 month before the first administration of investigational product
Those who has hypersensitivity to dutasteride or other 5-alpha reductase related inhibitors.
- (Part 1) Those who has hypersensitivity to tatto ink.
Those who have the screening(D-28~D-2) test results write below
- AST, ALT > 1.5 times higher than upper normal level
- Total bilirubin > 1.5 times higher than upper normal level
- eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- "Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR
- Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
- Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
- Those who receive following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration and Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product.
Those who exceeding smoke & alcohol consumption criteria.
- Smoke: > 10 cigarettes/day
- Caffeine: > 5 cups/day
- Alcohol > 210 g/week
- Those who take grapefruit within 7 days before the first administration of investigational product.
- Those who receive investigational product by participating in other clinical trial within 180 days before the first administration of investigational product.
- Those who donate whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
- Those who receive transfusion within 30 days before the first administration of investigational product.
- Those who are deemed inappropriate to participate in clinical trial by investigators.
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
Group - A1(Part 1)
Group - A2(Part 2)
Group - B1(Part 1)
Group - B2(Part 2)
Group - R(Part 1)
CKD-843 A 45mg
CKD-843 A 45mg
CKD-843 A 55mg
CKD-843 A 55mg
CKD-843-R