Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing SKYRIZI for Psoriasis

This is a Phase 1, first-in-human (FIH), randomly assigned, neither you nor the study doctors know who gets the real treatment, 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.

Official registry: https://clinicaltrials.gov/study/NCT07258745 · Chong Kun Dang Pharmaceutical · enrollment listed as 213

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SKYRIZI, SKYRIZI, or CKD-704. The registry lists allocation as randomized. This is a Phase 1, first-in-human (FIH), randomly assigned, neither you nor the study doctors know who gets the real treatment, 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.

They plan to enroll about 213 people at Warsaw. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: SKYRIZI, SKYRIZI, CKD-704

Primary outcome (registry wording): Maximum Observed Serum Concentration (Cmax)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 55 Years
  • 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

Public study contact (from the registry)

Anna Dryja, MD

+48 22 572 59 59

anna.dryja@pratia.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07258745 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07258745?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07258745?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary