Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Celltrion Healthcare

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Participants

Treatments: Biological: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07200986

CT-P52 1.1

Details and patient eligibility

About

This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.

Enrollment: 218 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups

CT-P52

Experimental group

Description:

80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: Ixekizumab

United States (US)-licensed Taltz

Active Comparator group

Description:

80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: Ixekizumab