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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Alopecia

Treatments: Drug: CKD-843 A 55mg(Multiple dose); Drug: CKD-843-R; Drug: CKD-843 A 45mg; Drug: CKD-843 A 55mg; Drug: CKD-843 A 45mg(Multiple dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05587699

A107_02PK2216

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 5 patient groups

Group - A1(Part 1)

Experimental group

Description:

CKD-843 A 45mg

Treatment:

Drug: CKD-843 A 45mg(Multiple dose)

Group - A2(Part 2)

Experimental group

Description:

CKD-843 A 45mg

Treatment:

Drug: CKD-843 A 45mg

Group - B1(Part 1)

Experimental group

Description:

CKD-843 A 55mg

Treatment:

Drug: CKD-843 A 55mg(Multiple dose)

Group - B2(Part 2)

Experimental group

Description:

CKD-843 A 55mg

Treatment:

Drug: CKD-843 A 55mg

Group - R(Part 1)

Active Comparator group

Description:

CKD-843-R

Treatment:

Drug: CKD-843-R