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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants

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

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants (NCT07258745) is a Phase 1 interventional studying Psoriasis, sponsored by Chong Kun Dang Pharmaceutical. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Psoriasis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 213 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Psoriasis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Capability of giving signed willing to sign a consent form 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 - 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 Should NOT Join This Trial: - 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 willing to sign a consent form 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 - Documented active or suspected malignancy or history of malignancy within 5 years prior to screening ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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

Treatments Being Tested

BIOLOGICAL

SKYRIZI

EU-sourced

BIOLOGICAL

SKYRIZI

US-licensed

BIOLOGICAL

CKD-704

Risankizumab biosimilar

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

MTZ powered by Pratia
Warsaw, Warszawa, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07258745), the sponsor (Chong Kun Dang Pharmaceutical), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07258745 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07258745?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07258745?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07258745. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07258745. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.