A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0007816

Enrollment

268

Registered

2022-10-19

Start date

2022-11-24

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This is a Phase 1, randomized, open-label, two-arm, parallel-group, single-dose study designed to compare the PK and safety of SC administration of CT-P47 AI and CT-P47 PFS in healthy subjects.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male or female subjects between the ages of 19 to 55 years,both inclusive. 2. Subject with a body weight of =60 and =100 kg for male and =50 and =100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. A medical history and/or condition that is considered significant 2. Clinically significant allergic reactions, hypersensitivity 3. History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis 4. Active or latent Tuberculosis 5. History of malignancy 6. Previous exposure to tocilizumab or any drug that targets IL-6

Design outcomes

Primary

Measure	Time frame
PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and maximum serum concentration (Cmax) of CT-P47 SC administration via AI versus PFS in healthy subjects	—

Secondary

Measure	Time frame
To evaluate additional PK, safety, and immunogenicity of CT-P47 SC administration via AI versus PFS in healthy subjects	—

Countries

Korea, Republic of

Contacts

Public ContactKyung-Sang Yu

Seoul National University Hospital

ksyu86@gmail.com+82-2-2668-7833

Outcome results