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

NCT ID: NCT05587699

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-10-17

Brief Summary

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

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group - A1(Part 1)

CKD-843 A 45mg

Group Type: EXPERIMENTAL

CKD-843 A 45mg(Multiple dose)

Intervention Type: DRUG

1 Injection/3 Month, 3 times Injections

Group - A2(Part 2)

CKD-843 A 45mg

Group Type: EXPERIMENTAL

CKD-843 A 45mg

Intervention Type: DRUG

Single Injection

Group - B1(Part 1)

CKD-843 A 55mg

Group Type: EXPERIMENTAL

CKD-843 A 55mg(Multiple dose)

Intervention Type: DRUG

1 Injection/3 Month, 3 times Injections

Group - B2(Part 2)

CKD-843 A 55mg

Group Type: EXPERIMENTAL

CKD-843 A 55mg

Intervention Type: DRUG

Single Injection

Group - R(Part 1)

CKD-843-R

Group Type: ACTIVE_COMPARATOR

CKD-843-R

Intervention Type: DRUG

0.5mg/day, 9 Month

Interventions

CKD-843 A 45mg(Multiple dose)

1 Injection/3 Month, 3 times Injections

Intervention Type: DRUG

CKD-843 A 45mg

Single Injection

Intervention Type: DRUG

CKD-843 A 55mg(Multiple dose)

1 Injection/3 Month, 3 times Injections

Intervention Type: DRUG

CKD-843 A 55mg

Single Injection

Intervention Type: DRUG

CKD-843-R

0.5mg/day, 9 Month

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minsoo Park, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A107_02PK2216

Identifier Type: -

Identifier Source: org_study_id