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Tests treatment safety and results for Psoriasis
Official title Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07258745
What this study is testing
What is SKYRIZI?
SKYRIZI is an investigational medicine, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- have acceptable venous access for blood collection
You likely can't join if
- 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...
- Medical history, findings of physical examination/laboratory tests indicate a clinically significant disorder, condition, or disease that, in the...
- Major surgery within 12 weeks prior to the randomization into the study
See the full eligibility 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...
- 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.
- 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...
- Any other laboratory value outside the reference range that the Investigator considers to be of clinical significance
- Abnormal vital signs(Systolic blood pressure \ 140 mmHg, Diastolic blood pressure \ 90 mmHg, Heart rate \ 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Warszawa, Poland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Warszawa, Poland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.