Alopecia
Conditions
Brief summary
A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.
Interventions
DRUGCKD-843 A 45mg(Multiple dose)
1 Injection/3 Month, 3 times Injections
DRUGCKD-843 A 45mg
Single Injection
DRUGCKD-843 A 55mg(Multiple dose)
1 Injection/3 Month, 3 times Injections
DRUGCKD-843 A 55mg
Single Injection
DRUGCKD-843-R
0.5mg/day, 9 Month
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0 to Day 271 | Pre-dose(Day 1 - 0 hour), Day 1 - 4 hours, Day 2, Day 8, Day 15, Day 30, Day 46, Day 61, Day 91, Day 91 - 4 hours, Day 92, Day 98, Day 105, Day 121, Day 136, Day 151, Day 181, Day 181 4 hours, Day 182, Day 188, Day 195, Day 211, Day 226, Day 241, Day 271 | Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271 |
Countries
South Korea
Outcome results
None listed