AlopeciaPhase 1NCT05587699
The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A
A Phase 1 study testing CKD-843 A 45mg(Multiple dose), CKD-843 A 45mg and CKD-843 A 55mg(Multiple dose) in people with Alopecia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- CKD-843 A 45mg(Multiple dose), CKD-843 A 45mg and CKD-843 A 55mg(Multiple dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2022to 17 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.
- Conditions
- Alopecia
- Being tested
- CKD-843 A 45mg(Multiple dose), CKD-843 A 45mg, CKD-843 A 55mg(Multiple dose), CKD-843 A 55mg, CKD-843-R
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-843 A 45mg(Multiple dose)Drug
1 Injection/3 Month, 3 times Injections
CKD-843 A 45mgDrug
Single Injection
CKD-843 A 55mg(Multiple dose)Drug
1 Injection/3 Month, 3 times Injections
CKD-843 A 55mgDrug
Single Injection
CKD-843-RDrug
0.5mg/day, 9 Month
| Study group | Role | What they receive |
|---|---|---|
| Group - A1(Part 1) | Experimental | CKD-843 A 45mg Receives: Drug: CKD-843 A 45mg(Multiple dose) |
| Group - A2(Part 2) | Experimental | CKD-843 A 45mg Receives: Drug: CKD-843 A 45mg |
| Group - B1(Part 1) | Experimental | CKD-843 A 55mg Receives: Drug: CKD-843 A 55mg(Multiple dose) |
| Group - B2(Part 2) | Experimental | CKD-843 A 55mg Receives: Drug: CKD-843 A 55mg |
| Group - R(Part 1) | Active comparator | CKD-843-R Receives: Drug: CKD-843-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0 to Day 271
Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start15 Nov 2022
- Primary completion15 Sep 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minsoo Park, M.D., Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587699
- Sponsor's protocol ID
- A107_02PK2216
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05587699
- Acronym / sponsor ID
- A107_02PK2216
- Conditions
- Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group - A1(Part 1) | Experimental | Drug: CKD-843 A 45mg(Multiple dose)CKD-843 A 45mg |
| Group - A2(Part 2) | Experimental | Drug: CKD-843 A 45mgCKD-843 A 45mg |
| Group - B1(Part 1) | Experimental | Drug: CKD-843 A 55mg(Multiple dose)CKD-843 A 55mg |
| Group - B2(Part 2) | Experimental | Drug: CKD-843 A 55mgCKD-843 A 55mg |
| Group - R(Part 1) | Active comparator | Drug: CKD-843-RCKD-843-R |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Those who aged between 19 to 50
- (Part 1) Those who are diagnosed to androgenic alopecia and meet criteria BASP grade
- (Part 1) Those who consent to the condition write below
- (Part 2) Those who are healthy male (Regardless of alopecia)
- Those who has body weight ≥ 55kg
Key exclusion criteria (28 listed)
- 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
- 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.
- Those who have the screening(D-28~D-2) test results write below
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-843 A 45mg(Multiple dose)1 Injection/3 Month, 3 times Injections | Drug | Group - A1(Part 1) |
| CKD-843 A 45mgSingle Injection | Drug | Group - A2(Part 2) |
| CKD-843 A 55mg(Multiple dose)1 Injection/3 Month, 3 times Injections | Drug | Group - B1(Part 1) |
| CKD-843 A 55mgSingle Injection | Drug | Group - B2(Part 2) |
| CKD-843-R0.5mg/day, 9 Month | Drug | Group - R(Part 1) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minsoo Park, M.D., Ph.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-843 A 45mg(Multiple dose), CKD-843 A 45mg and CKD-843 A 55mg(Multiple dose) in people with Alopecia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.