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

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT07258745
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • SKYRIZI — BIOLOGICAL
    EU-sourced
  • SKYRIZI — BIOLOGICAL
    US-licensed
  • CKD-704 — BIOLOGICAL
    Risankizumab biosimilar

Study Details

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.

Key Dates

Start date
Nov 26, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
213 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CKD-704
    Singe dose pre-filled syringe, 150mg/ml
  • Active Comparator: EU-Skyrizi
    Singe dose pre-filled syringe, 150mg/ml
  • Active Comparator: US-Skyrizi
    Singe dose pre-filled syringe, 150mg/ml

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) [ Time Frame: up to approximately 146 days ]

Central Contacts

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