Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
NCT07200986
Phase
Phase 1
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Celltrion
Start date
2025-09-17
Number of sites
- Summary
- This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
- Short title
- Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
- Official title
- A Phase 1, Randomized, Double-blind, Two-arm, Parallel-Group, Single-dose Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-03-31
- First posted
- 2025-10-01
- Registry last updated
- 2025-12-31
- Primary completion date
- 2026-03-31
- Start date
- 2025-09-17
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Celltrion
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07200986
- ClinicalTrials.gov ID
- NCT07200986
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
AUC0-inf
Timeframe: Day 85
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Cmax
Timeframe: Day 85
PK similarity demonstration in terms of maximum serum concentration
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 19 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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
Sources for eligibility
- Inje University Busan Paik HospitalBusan, South Korea
- CHA Bundang Medical CenterSeongnam-si, South Korea
- Seoul National University Bundang HospitalSeongnam-si, South Korea
- Chungbuk National University HospitalCheongju-si, South Korea
- Seoul National University HospitalSeoul, South Korea
Sources for sites