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

Primary Purpose

Alopecia

Status
Not yet recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-843 A 45mg(Multiple dose)
CKD-843 A 45mg
CKD-843 A 55mg(Multiple dose)
CKD-843 A 55mg
CKD-843-R
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group - A1(Part 1)

Group - A2(Part 2)

Group - B1(Part 1)

Group - B2(Part 2)

Group - R(Part 1)

Arm Description

CKD-843 A 45mg

CKD-843 A 45mg

CKD-843 A 55mg

CKD-843 A 55mg

CKD-843-R

Outcomes

Primary Outcome Measures

AUC0 to Day 271
Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271

Secondary Outcome Measures

Full Information

First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05587699
Brief Title
The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A
Official Title
A Randomized, Open-label, Multiple-dose and Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A in Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 26, 2022 (Anticipated)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
September 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group - A1(Part 1)
Arm Type
Experimental
Arm Description
CKD-843 A 45mg
Arm Title
Group - A2(Part 2)
Arm Type
Experimental
Arm Description
CKD-843 A 45mg
Arm Title
Group - B1(Part 1)
Arm Type
Experimental
Arm Description
CKD-843 A 55mg
Arm Title
Group - B2(Part 2)
Arm Type
Experimental
Arm Description
CKD-843 A 55mg
Arm Title
Group - R(Part 1)
Arm Type
Active Comparator
Arm Description
CKD-843-R
Intervention Type
Drug
Intervention Name(s)
CKD-843 A 45mg(Multiple dose)
Intervention Description
1 Injection/3 Month, 3 times Injections
Intervention Type
Drug
Intervention Name(s)
CKD-843 A 45mg
Intervention Description
Single Injection
Intervention Type
Drug
Intervention Name(s)
CKD-843 A 55mg(Multiple dose)
Intervention Description
1 Injection/3 Month, 3 times Injections
Intervention Type
Drug
Intervention Name(s)
CKD-843 A 55mg
Intervention Description
Single Injection
Intervention Type
Drug
Intervention Name(s)
CKD-843-R
Intervention Description
0.5mg/day, 9 Month
Primary Outcome Measure Information:
Title
AUC0 to Day 271
Description
Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271
Time Frame
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minsoo Park, M.D., Ph.D
Phone
+82-2-2228-0400
Email
minspark@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minsoo Park, M.D., Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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

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