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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05587699
Recruitment Status : Not yet recruiting
First Posted : October 20, 2022
Last Update Posted : October 20, 2022
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Alopecia 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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 26, 2022
Estimated Primary Completion Date : September 10, 2023
Estimated Study Completion Date : September 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group - A1(Part 1)
CKD-843 A 45mg
 Drug: CKD-843 A 45mg(Multiple dose)
1 Injection/3 Month, 3 times Injections
Experimental: Group - A2(Part 2)
CKD-843 A 45mg
 Drug: CKD-843 A 45mg
Single Injection
Experimental: Group - B1(Part 1)
CKD-843 A 55mg
 Drug: CKD-843 A 55mg(Multiple dose)
1 Injection/3 Month, 3 times Injections
Experimental: Group - B2(Part 2)
CKD-843 A 55mg
 Drug: CKD-843 A 55mg
Single Injection
Active Comparator: Group - R(Part 1)
CKD-843-R
 Drug: CKD-843-R
0.5mg/day, 9 Month


Outcome Measures
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Primary Outcome Measures :
  1. AUC0 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 ]
    Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05587699


Contacts
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Contact: Minsoo Park, M.D., Ph.D +82-2-2228-0400 minspark@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Minsoo Park, M.D., Ph.D Severance Hospital
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT05587699    
Other Study ID Numbers: A107_02PK2216
First Posted: October 20, 2022    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical