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

NCT07258745 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2025-12-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

SKYRIZI

EU-sourced

BIOLOGICAL

SKYRIZI

US-licensed

BIOLOGICAL

CKD-704

Risankizumab biosimilar

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07258745 on ClinicalTrials.gov