A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Celltrion Healthcare

Status and phase: Unknown; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: EU-approved RoActemra,; Biological: CT-P47

Study type: Interventional

Funder types: Industry

Identifiers

NCT05188378

CT-P47 1.1

Details and patient eligibility

About

A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Full description

Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.

Enrollment: 300 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• 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

• A medical history and/or condition that is considered significant
• Clinically significant allergic reactions, hypersensitivity
• History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
• Active or latent Tuberculosis
• History of malignancy
• Previous exposure to tocilizumab or any drug that targets IL-6

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 2 patient groups

CT-P47

Experimental group

Description:

162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: CT-P47

EU-approved RoActemra

Active Comparator group

Description:

162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: EU-approved RoActemra,