A Phase 1 Study to Compare the Pharmacokinetics and Safety of CT-P13 (CT-P13 SC) Auto-injector and Pre-filled Syringe for Subcutaneous Administration in Healthy Adult Subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0009574
- Lead Sponsor
- Celltrion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 148
1.Healthy male and female subjects between the ages of 19 and 55 years, both inclusive (healthy was defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead electrocardiogram [ECG], and clinical laboratory tests prior to the randomization).
2.Subject with body mass index (BMI) between 18.0 and 29.9 kg/m2 and a total body weight between 55.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
3.Subject who was informed of the full nature and purpose of the study, including possible risks and side effects, had the ability to cooperate with the investigator and was given ample time and opportunity to read or understand verbal and/or written instructions, and had signed voluntarily and dated the written ICF prior to performing any of the screening procedures.
4.For both male and female subjects, the subject and his or her partner of childbearing potential who agreed to use 1 of the following medically acceptable methods of contraception during the study and for 6 months after the administration of study drug (excluding women who were not of childbearing potential and men who had been sterilized):
-Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
-Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
-Intra-uterine device
Intra uterine devices and hormonal methods for contraception were used for at least 1 menstruation cycle prior to the administration of the study drug.
Male and female subjects and their partners who had been surgically sterilized for less than 6 months prior to the date of informed consent had to agree to use any of the medically acceptable methods of contraception. Menopausal females had to experience their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential.
1.Subject who has had previous exposure to infliximab or an investigational or licensed biosimilar of infliximab. Also, subject who has had exposure to a monoclonal antibody or current use of a biologic agent (including but not limited to tumor necrosis factor-alpha blockers) within the last 24 weeks prior to the administration of the study drug (Day 0).
2.Subject who has a current or history of any of the following infections:
•Known infection with hepatitis B or hepatitis C (active or carrier state) or infection with human immunodeficiency virus, or syphilis.
•History of invasive systemic fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis, etc.) or other opportunistic infections judged by the investigator, including local fungal infections or a history of herpes zoster.
•History of systemic or local infection, a known risk for developing sepsis, and/or known active inflammatory process or evidence of an infection requiring in-subject hospitalization or intravenous antibiotics within 24 weeks prior to the administration of the study drug (Day 0).
3.Subject who has a tuberculosis (TB) history and/or condition including 1 or more of the following:
•Current diagnosis of active TB or latent TB (defined as a positive result for interferon-? release assay [IGRA] with chest x-ray negative for a lesion, and without any sign or symptom of TB)
•History of active TB or latent TB
•History of close contact with a person with active TB, travel to areas with a high incidence of TB within 8 weeks prior to the administration of the study drug (Day 0) or plans to travel to the area in which TB is prevalent during the study (from the date the subject signs the ICF until the EOS visit)
If the result of IGRA is indeterminate at Screening, retest will be allowed only once during the Screening period. If the repeated IGRA result is again indeterminate or positive, the subject will be excluded from the study. If the repeated IGRA result is negative, the subject may be included in the study.
4.Subject who has a medical history and/or condition including 1 or more of the following:
•History and/or current presence of clinically significant atopy (e.g., allergic asthma, eczematous dermatitis), known or suspected clinically relevant hypersensitivity or allergic reactions to any of the excipients of study drug, other murine and human proteins or immunoglobulin products.
•History and/or current presence of known or suspected clinically relevant hypersensitivity or allergic reactions to premedications (oral loratadine [10 mg], oral paracetamol [1000 mg]) and any of the excipients of these premedications.
•History of and/or current cardiac (including heart failure, myocardial infarction, etc.), gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological (including pancytopenia, aplastic anemia or blood dyscrasia, etc.), metabolic (including diabetes mellitus), or pulmonary disease classified as clinically significant by the investigator.
•History of any malignancy.
•History and/or current presence of gallbladder or bile duct disease (except for asymptomatic cholelithiasis), acute or chronic pancreatitis, or hepatic disease (e.g., cirrhosis) considered clinically significant by the investigator.
•History of illness within 4 weeks prior to the administration of the study drug (Day 0) that is classified as clinically significant by the i
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method