The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A

Study Overview
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Brief Summary
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A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.

Official Title
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A Randomized, Open-label, Multiple-dose and Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A in Male Subjects

Conditions
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Alopecia

Intervention / Treatment
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* Drug: CKD-843 A 45mg(Multiple dose)
* Drug: CKD-843 A 45mg
* Drug: CKD-843 A 55mg(Multiple dose)
* Drug: CKD-843 A 55mg
* Drug: CKD-843-R


Participation Criteria
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Eligibility Criteria
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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.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group - A1(Part 1)<br>CKD-843 A 45mg | Drug: CKD-843 A 45mg(Multiple dose)<br>* 1 Injection/3 Month, 3 times Injections<br>|
| Experimental: Group - A2(Part 2)<br>CKD-843 A 45mg | Drug: CKD-843 A 45mg<br>* Single Injection<br>|
| Experimental: Group - B1(Part 1)<br>CKD-843 A 55mg | Drug: CKD-843 A 55mg(Multiple dose)<br>* 1 Injection/3 Month, 3 times Injections<br>|
| Experimental: Group - B2(Part 2)<br>CKD-843 A 55mg | Drug: CKD-843 A 55mg<br>* Single Injection<br>|
| Active Comparator: Group - R(Part 1)<br>CKD-843-R | Drug: CKD-843-R<br>* 0.5mg/day, 9 Month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0 to Day 271 | Area under the concentration-time curve from time Day 1(Pre-dose) 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 |