PsoriasisPhase 1NCT07258745
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants
A Phase 1 study testing SKYRIZI and CKD-704 in people with Psoriasis, run by Chong Kun Dang Pharmaceutical at 1 site in Poland.
Trial summary
This is a Phase 1, first-in-human (FIH), randomized, double-blind, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- SKYRIZI and CKD-704
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 sitePoland
- Study dates
- 26 Nov 2025to 30 Sep 2026
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capability of giving signed informed consent and complying with the requirements and restrictions listed in the ICF and Protocol
- Healthy male or female, 18 to 55 years (inclusive) at the time of signing the ICF
- smokes ≤ 10 cigarettes per week within 3 months of screening
- abstain from alcohol from 48 hours prior to study intervention administration and keeping alcohol consumption within WHO limits (more than 14 units per week spread over 3 or more days, equivalent to 6 pints of average strength beer or 6 medium glasses [175 mL] of wine)
- have acceptable venous access for blood collection
- Female participants are eligible to participate if they are not pregnant, not breastfeeding
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- Male participants must refrain from donating sperm from screening (signing the ICF) until at least 30 days after EOS visit
- All participants must be willing to use effective/highly effective methods of contraception during the study period
- Participants are willing and able to be confined to the clinical unit prior to and during the study intervention administration and required follow-up periods.
Who cannot join
- History of previous exposure to any anti-IL-12/23 or anti-IL-23 treatment
- History of relevant drug and/or food allergies
- History of hypersensitivity to Skyrizi or their constituents
- Presence of psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- Medical history, findings of physical examination/laboratory tests indicate a clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to participant safety
- Major surgery within 12 weeks prior to the randomization into the study
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- Documented active or suspected malignancy or history of malignancy within 5 years prior to screening
- Positive tests for hepatitis B surface antigen, Hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
- Positive test for severe acute respiratory syndrome coronavirus 2 on admission (optional)
- Any current active infections or any recent history (within 1 week prior to study intervention administration) of active infections
- Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis
- Abnormal hepatic, renal, or hematological laboratory tests. In such cases, the assessment may be repeated once at screening and admission. The Investigator will check reassessment results to decide if the value is clinically significant and if participant is eligible to receive the treatment
- Any other laboratory value outside the reference range that the Investigator considers to be of clinical significance
- Abnormal vital signs(Systolic blood pressure < 90 mmHg or > 140 mmHg, Diastolic blood pressure < 50 mmHg or > 90 mmHg, Heart rate < 45 or > 100 beats per minute)
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG
- Any past or concurrent medical conditions, or clinically important active infection that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion
- Have used any prescription or non-prescription medicines or vitamins within 7 days or 5 half-lives (whichever is longer) of admission, unless in the Investigator's opinion will not affect determination of safety or other study assessments
- Male or females participating in any other clinical trial at the time of consenting
- Have received any investigational drug within 30 days prior to screening, with minimal washout of at least 5-half-lives of any previous investigational drug, whichever is longer
- Have received live vaccines during the past 4 weeks before screening or have the intention to receive vaccination during the 21-week treatment and assessment period
- Participant has donated blood (> 500 mL) or blood products within 2 months (56 days) prior to screening
- History of drug abuse or alcohol abuse as judged by the Investigator or designee
- Participant is affiliated with the site or Sponsor and/or may be considered to be consenting under duress
- Participant is unlikely to co-operate with the requirements of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
MTZ powered by Pratia
Warsaw, Warszawa, 02-172
+48225725959, anna.dryja@pratia.com
About this study
Official title: A Randomized, Double-Blind, Single-Dose, Parallel-Group, Three-Arm Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Profiles of CKD-704 (Risankizumab Biosimilar), EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants
This is a Phase 1, first-in-human (FIH), randomized, double-blind, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.
- Conditions
- Psoriasis
- Being tested
- SKYRIZI, CKD-704
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKYRIZIBiological
EU-sourced
SKYRIZIBiological
US-licensed
CKD-704Biological
Risankizumab biosimilar
| Study group | Role | What they receive |
|---|---|---|
| CKD-704 | Experimental | Singe dose pre-filled syringe, 150mg/ml Receives: Biological: CKD-704 |
| EU-Skyrizi | Active comparator | Singe dose pre-filled syringe, 150mg/ml Receives: Biological: SKYRIZI |
| US-Skyrizi | Active comparator | Singe dose pre-filled syringe, 150mg/ml Receives: Biological: SKYRIZI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of risankizumab.
Measured: up to approximately 146 days
AUC From Time 0 to Infinity (AUCinf)
AUCinf of risankizumab
Measured: Up to approximately 146 days
Secondary outcomes (4)
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
AUCt of risankizumab
Measured: Up to approximately 146 days
Terminal Phase Elimination Hhalf-life (t1/2)
Terminal phase elimination half-life (t1/2) of risankizumab.
Measured: Up to approximately 146 days
Time to Cmax (Tmax)
Time to Cmax of risankizumab
Measured: Up to approximately 146 days
Safety and tolerability
Incidence and characteristics (severity, etc) of AEs
Measured: Up to approximately 146 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start26 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258745
- Sponsor's protocol ID
- A148_01PK2408
- Other IDs
- 2025-522345-21-00, 2025
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single-Dose, Parallel-Group, Three-Arm Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Profiles of CKD-704 (Risankizumab Biosimilar), EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07258745
- Acronym / sponsor ID
- A148_01PK2408
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Dec 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 Phase 1, first-in-human (FIH), randomized, double-blind, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD-704 | Experimental | Biological: CKD-704Singe dose pre-filled syringe, 150mg/ml |
| EU-Skyrizi | Active comparator | Biological: SKYRIZISinge dose pre-filled syringe, 150mg/ml |
| US-Skyrizi | Active comparator | Biological: SKYRIZISinge dose pre-filled syringe, 150mg/ml |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Capability of giving signed informed consent and complying with the requirements and restrictions listed in the ICF and Protocol
- Healthy male or female, 18 to 55 years (inclusive) at the time of signing the ICF
- smokes ≤ 10 cigarettes per week within 3 months of screening
- abstain from alcohol from 48 hours prior to study intervention administration and keeping alcohol consumption within WHO limits (more than 14 units per week spread over 3 or more days, equivalent to 6 pints of average strength beer or 6 medium glasses [175 mL] of wine)
- have acceptable venous access for blood collection
Key exclusion criteria (24 listed)
- History of previous exposure to any anti-IL-12/23 or anti-IL-23 treatment
- History of relevant drug and/or food allergies
- History of hypersensitivity to Skyrizi or their constituents
- Presence of psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- Medical history, findings of physical examination/laboratory tests indicate a clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to participant safety
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 |
|---|---|---|
| SKYRIZIEU-sourced | Biological | EU-Skyrizi |
| SKYRIZIUS-licensed | Biological | US-Skyrizi |
| CKD-704Risankizumab biosimilar | Biological | CKD-704 |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: up to approximately 146 days
Maximum observed serum concentration (Cmax) of risankizumab.
AUC From Time 0 to Infinity (AUCinf)
Time frame: Up to approximately 146 days
AUCinf of risankizumab
4 secondary outcomes
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
Time frame: Up to approximately 146 days
Terminal Phase Elimination Hhalf-life (t1/2)
Time frame: Up to approximately 146 days
Time to Cmax (Tmax)
Time frame: Up to approximately 146 days
Safety and tolerability
Time frame: Up to approximately 146 days
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 19 Dec 2025.
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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.
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 SKYRIZI and CKD-704 in people with Psoriasis, run by Chong Kun Dang Pharmaceutical at 1 site in Poland.
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 9 inclusion and 24 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 19 Dec 2025. 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 Poland. 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?
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 Anna Dryja, MD (+48 22 572 59 59, anna.dryja@pratia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Serum Concentration (Cmax) (time frame: up to approximately 146 days). The study lists 2 primary outcomes in all. 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 19 Dec 2025.