Actively Recruiting
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants
Led by Chong Kun Dang Pharmaceutical · Updated on 2025-12-19
213
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to give signed informed consent and follow study requirements
- Healthy males or females aged 18 to 55 years at consent
- Smoking up to 10 cigarettes per week within 3 months before screening
- Abstain from alcohol 48 hours before treatment and keep consumption within WHO limits
- Have acceptable veins for blood collection
- Females must not be pregnant or breastfeeding
- Males must avoid sperm donation from consent until 30 days after study end
- Willing to use effective contraception during study
- Willing and able to stay in the clinical unit before and during treatment and follow-up
You will not qualify if you...
- Previous treatment with anti-IL-12/23 or anti-IL-23 drugs
- History of relevant drug or food allergies
- Allergy to Skyrizi or its ingredients
- Psychiatric disorders or altered mental status preventing consent or study procedures
- Medical conditions posing safety risks as judged by investigator
- Major surgery within 12 weeks before study
- Active or past malignancy within 5 years
- Positive tests for hepatitis B, hepatitis C, or HIV
- Positive test for COVID-19 on admission
- Current active infections or recent infections within 1 week before treatment
- History or evidence of tuberculosis infection
- Abnormal liver, kidney, or blood tests deemed clinically significant
- Abnormal vital signs beyond specified blood pressure or heart rate ranges
- Abnormal ECG findings that are clinically important
- Medical conditions or infections increasing risk or interfering with study
- Use of medicines or vitamins within 7 days or 5 half-lives before admission, unless safe
- Participation in other clinical trials at consent
- Received investigational drugs within 30 days before screening
- Received live vaccines within 4 weeks before screening or planned during study
- Blood donation over 500 mL within 56 days before screening
- History of drug or alcohol abuse
- Affiliation with study site or sponsor or consenting under duress
- Unlikely to cooperate with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MTZ powered by Pratia
Warsaw, Warszawa, Poland, 02-172
Actively Recruiting
Research Team
A
Anna Dryja, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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