Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
- Registration Number
- NCT07200986
- Lead Sponsor
- Celltrion
- Brief Summary
This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 218
Inclusion Criteria
- Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
- Subject with a body weight of ≥60 and ≤90 kg for male and ≥50 and ≤90 kg for female, and a BMI between 18.0 and 29.9 kg/m2 (both inclusive) when rounded to the nearest tenth.
- Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.
Exclusion Criteria
- A medical history and/or condition that is considered significant
- Clinically significant allergic reactions, hypersensitivity
- History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis
- Active or latent Tuberculosis
- Previous monoclonal antibody or fusion protein treatment, or current use of any biologics
- Plans to donate whole blood or blood components during the study
- Male subject who is planning to have child or donate sperms within 10 weeks after the study drug administration. Female subject who is currently pregnant or lactating, or planning to be pregnant or to breastfeed within 10 weeks after the administration of the study drug
- Reasonable evidence or history of drug/alcohol/smoking abuse
- Presence of tattoos, sunburn, or other skin disturbances on the injection site
- Vulnerable subject
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT-P52 Ixekizumab 80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS) United States (US)-licensed Taltz Ixekizumab 80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)
- Primary Outcome Measures
Name Time Method AUC0-inf Day 85 Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Cmax Day 85 PK similarity demonstration in terms of maximum serum concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Inje University Busan Paik Hospital
🇰🇷Busan, Busanjin-gu, South Korea
CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
🇰🇷Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital
🇰🇷Seoul, South Korea
Inje University Busan Paik Hospital🇰🇷Busan, Busanjin-gu, South Korea