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

NCT07258745 | Recruiting Phase 1

• 2 other identifiers: A148_01PK24082025-522345-21-00
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Serum Concentration (Cmax)

  Maximum observed serum concentration (Cmax) of risankizumab.

  up to approximately 146 days

• AUC From Time 0 to Infinity (AUCinf)

  AUCinf of risankizumab

  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)

  Up to approximately 146 days

• Terminal Phase Elimination Hhalf-life (t1/2)

  Up to approximately 146 days

• Time to Cmax (Tmax)

  Up to approximately 146 days

• Safety and tolerability

  Up to approximately 146 days

Study Arms (3)

CKD-704

EXPERIMENTAL

Singe dose pre-filled syringe, 150mg/ml

Biological: CKD-704

EU-Skyrizi

ACTIVE COMPARATOR

Singe dose pre-filled syringe, 150mg/ml

Biological: SKYRIZI

US-Skyrizi

ACTIVE COMPARATOR

Singe dose pre-filled syringe, 150mg/ml

Biological: SKYRIZI

Interventions

SKYRIZI BIOLOGICAL

EU-sourced

EU-Skyrizi

CKD-704 BIOLOGICAL

Risankizumab biosimilar

CKD-704

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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.

You may not qualify 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 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

MTZ powered by Pratia

Warsaw, Warszawa, 02-172, Poland

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anna Dryja, MD

CONTACT

+48 22 572 59 59; anna.dryja@pratia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

PL (1)