Androgenetic AlopeciaPhase 3NCT06916793
A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
A Phase 3 study testing CKD-843 dose#1, CKD-843 dose#2 and Dutasteride Capsules in people with Androgenetic Alopecia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- CKD-843 dose#1, CKD-843 dose#2 and Dutasteride Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2025to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male of age 18-50 years
- Clinical Diagnosis of Androgenetic Alopecia
- Written informed consent
Who cannot join
- Other types of Alopecia or other diseases that can cause hair loss
- Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
- Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
- Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
OhSang Kwon, MD, PhD, +2-2072-2417, oskwon@snu.ac.kr
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia
This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia
Read the detailed description
The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.
- Conditions
- Androgenetic Alopecia
- Being tested
- CKD-843 dose#1, CKD-843 dose#2, Placebo of CKD-843 dose, Dutasteride Capsules, Placebo of Dutasteride Capsule
- 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 dose#1Drug
IM injection every 3 months for 12 months
CKD-843 dose#2Drug
IM injection every 3 months for 12 months
Placebo of CKD-843 doseDrug
IM injection every 3 months for 12 months
Dutasteride CapsulesDrug
oral, once daily, 12 months
Placebo of Dutasteride CapsuleDrug
oral, once daily, 12 months
| Study group | Role | What they receive |
|---|---|---|
| Test Group1 | Experimental | CKD-843 dose#1 + Placebo of Dutasteride Capsule Receives: Drug: CKD-843 dose#1; Drug: Placebo of Dutasteride Capsule |
| Test Group2 | Experimental | CKD-843 dose#2 + Placebo of Dutasteride Capsule Receives: Drug: CKD-843 dose#2; Drug: Placebo of Dutasteride Capsule |
| Placebo-controlled Group | Placebo comparator | Placebo of CKD-843 dose + Placebo of Dutasteride Capsule Receives: Drug: Placebo of CKD-843 dose; Drug: Placebo of Dutasteride Capsule |
| Active-controlled Group | Active comparator | Placebo of CKD-843 dose + Dutasteride Capsules Receives: Drug: Placebo of CKD-843 dose; Drug: Dutasteride Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of hair Changes
from Baseline at Week24 of total number of hair changes
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start8 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- OhSang Kwon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916793
- Sponsor's protocol ID
- A107_03AGA2318
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06916793
- Acronym / sponsor ID
- A107_03AGA2318
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Apr 2025 (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.
This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia
Detailed description
The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group1 | Experimental | Drug: CKD-843 dose#1, Drug: Placebo of Dutasteride CapsuleCKD-843 dose#1 + Placebo of Dutasteride Capsule |
| Test Group2 | Experimental | Drug: CKD-843 dose#2, Drug: Placebo of Dutasteride CapsuleCKD-843 dose#2 + Placebo of Dutasteride Capsule |
| Placebo-controlled Group | Placebo comparator | Drug: Placebo of CKD-843 dose, Drug: Placebo of Dutasteride CapsulePlacebo of CKD-843 dose + Placebo of Dutasteride Capsule |
| Active-controlled Group | Active comparator | Drug: Placebo of CKD-843 dose, Drug: Dutasteride CapsulesPlacebo of CKD-843 dose + Dutasteride Capsules |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male of age 18-50 years
- Clinical Diagnosis of Androgenetic Alopecia
- Written informed consent
Key exclusion criteria (4 listed)
- Other types of Alopecia or other diseases that can cause hair loss
- Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
- Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
- Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose
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 dose#1IM injection every 3 months for 12 months | Drug | Test Group1 |
| CKD-843 dose#2IM injection every 3 months for 12 months | Drug | Test Group2 |
| Placebo of CKD-843 doseIM injection every 3 months for 12 months | Drug | Active-controlled Group, Placebo-controlled Group |
| Dutasteride Capsulesoral, once daily, 12 months | Drug | Active-controlled Group |
| Placebo of Dutasteride Capsuleoral, once daily, 12 months | Drug | Placebo-controlled Group, Test Group1, Test Group2 |
Primary outcome
Total number of hair Changes
Time frame: Baseline, Week 24
from Baseline at Week24 of total number of hair changes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
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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.
OhSang Kwon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CKD-843 dose#1, CKD-843 dose#2 and Dutasteride Capsules in people with Androgenetic 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OhSang Kwon, MD, PhD (+2-2072-2417, oskwon@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of hair Changes (time frame: Baseline, Week 24). 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 3 Sep 2026.