Healthy
Conditions
Brief summary
This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm, all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks during which PK, safety, and immunogenicity measurements were made. The randomization to treatment assignment was stratified by body weight (≥80 kg vs. \<80 kg) as measured on baseline (Day -1), gender (male vs. female) and study center.
Interventions
BIOLOGICALCT-P17
subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects who meet all of the following criteria will be considered eligible to participate in the clinical study: 1. Healthy male or female subjects, between the ages of 18 and 55 years, both inclusive (healthy is 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 administration of the study drug). 2. Subject with C-reactive protein ≤1.5 times the upper limit of normal (ULN). 3. Subject has adequate liver function as determined by following results: * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 times ULN and * Total bilirubin ≤1.5 times ULN. 4. Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. The subject has the ability and agrees to cooperate with the investigator and must sign and date the written informed consent prior to performing any of the screening procedures. 5. BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth. 6. Subject and their partner of childbearing potential must agree to use highly effective method of contraception as specified in Section 5.8.2 throughout the study and for 5 months after the administration of the study drug. A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Male and female subjects and their partners who have been surgically sterilized for less than 24 weeks prior to the date of informed consent must agree to use any medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential.
Exclusion criteria
Subjects who meet any of the following criteria will not be considered eligible to participate in the clinical study: 1. Subject has a medical history and/or condition including one or more of the following disease(s): * 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 of infection with hepatitis B (active or carrier of hepatitis B), hepatitis C, human immunodeficiency virus (HIV) or syphilis. However, a subject with history of hepatitis B virus is allowed if resolved. Subject will be enrolled based on hepatitis B infection eligibility criteria, specified in Section 6.2.3. * 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 and/or current cardiac (including New York Heart Association class III/IV heart failure), gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological (including pancytopenia, aplastic anemia or blood dyscrasia, etc.), metabolic (including diabetes mellitus), or pulmonary disease classed as significant by the investigator. * History of any malignancy. * 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-patient hospitalization or intravenous antibiotics within 24 weeks prior to the administration of the study drug (Day 1). 2. Subject is considered to have a significant abnormal cardiac function in investigator's discretion determined by the laboratory results. 3. Subject underwent surgical intervention or an operation within 4 weeks prior to the administration of the study drug (Day 1) or plans to have a surgical procedure during the study period. 4. Subject has active tuberculosis (TB), latent TB (defined as a positive result for interferon-γ release assay \[IGRA\] with no active lesion in examination of chest X-ray without any sign or symptom of TB), a history of TB, had close contact with a person with active TB or traveled to areas within a high incidence of TB within 8 weeks prior to the administration of the study drug (Day 1) or has plans to travel to the area in which TB is prevalent during the study period. 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. 5. Female subject is pregnant or lactating or planning to be pregnant or to breastfeed before, during, or within 5 months after the administration of the study drug (Day 1). 6. Male subject is planning to father a child or donate sperm within 5 months after the administration of the study drug (Day 1). 7. Subject has received tumor necrosis factor-α blockers, or subject who has had exposure of a biologic agent (including but not limited to monoclonal antibodies or fusion protein) within 6 months prior to the administration of the study drug (Day 1). 8. Subject used prescription (excluding hormonal birth control), over-the-counter drugs, dietary supplements, or herbal remedies that could affect the outcome of the study within 2 weeks prior to the administration of the study drug (Day 1). 9. Subject has undergone treatment with an investigational drug or participated in another clinical trial for healthy subject or bioequivalence test within 90 days or 5 half-lives (whichever is longer) prior to the administration of the study drug (Day 1) or plan to do so during the study. 10. Subject received a live or live-attenuated vaccine within 4 weeks prior to the administration of the study drug (Day 1) or plan to do so until the 6 months after Day 1. 11. Subject has donated or lost 450 mL or more of whole blood within 8 weeks, or donated blood components within 4 weeks prior to the administration of the study drug (Day 1). 12. Subject shows reasonable evidence of drug abuse (positive result for drug urine test and/or the opinion of the investigator). 13. Subject has a history or presence of regular consumption exceeding an average weekly intake of \>21 units of alcohol in recent 12 weeks prior to the administration of the study drug (Day 1). One unit is equivalent to a half-pint (285 mL) of beer/lager, one measure (25 mL) of spirits, or one small glass (125 mL) of wine. Subject is unwilling to avoid use of alcohol or alcohol containing foods, medications, or beverages within 24 hours prior to admission (Day -1), and each study visit until completion of the study. 14. Subject has smoked 10 or more cigarettes per day in the recent 12 weeks prior to the administration of the study drug (Day 1) and/or is unable to refrain from smoking up to 24 hours after the administration of the study drug. 15. In the opinion of the investigator, the subject is not eligible for the study participation for any reason (including clinical laboratory results) or shows evidence of a condition (e.g., psychological or emotional problem, any disorder or resultant therapy) that is likely to invalidate an informed consent or limit the ability of the subject to comply with the protocol requirements. Subject is unable to understand the protocol requirements, instructions, study-related restrictions, or the nature, scope, and possible consequences of the clinical study or is unable to give written informed consent or to comply fully with the protocol. 16. Subject is vulnerable (e.g., employees of the study center or any other individuals involved with the conduct of the study, or immediate family members of such individuals, persons kept in prison, or other institutionalized persons by law enforcement).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last)) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Elimination Rate Constant (λz) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Apparent Total Body Clearance (CL/F) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Summary of Immunogenicity Assay | Day 1 predose, Days 15, 29, 57, 71 postdose | To evaluate immunogenicity of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Time to Maximum Serum Concentration (Tmax) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects |
| Terminal Elimination Half-life (t1/2) | Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose | To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auto Injector a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks | 93 |
| Pre-filled Syringe a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks | 87 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Auto Injector | Pre-filled Syringe | Total |
|---|---|---|---|
| Age, Continuous | 35.2 years | 36.7 years | 35.9 years |
| Day -1 BMI | 25.26 kg/m2 STANDARD_DEVIATION 2.967 | 25.50 kg/m2 STANDARD_DEVIATION 2.939 | 25.38 kg/m2 STANDARD_DEVIATION 2.948 |
| Day -1 weight category Weight <80 kg | 65 Participants | 62 Participants | 127 Participants |
| Day -1 weight category Weight ≥80 kg | 28 Participants | 25 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 25 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 62 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Female fertility status Not applicable (male) | 48 Participants | 42 Participants | 90 Participants |
| Female fertility status Post-menopausal | 3 Participants | 0 Participants | 3 Participants |
| Female fertility status Potentially able to bear children | 32 Participants | 36 Participants | 68 Participants |
| Female fertility status Surgically sterilized | 10 Participants | 9 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 39 Participants | 73 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 47 Participants | 100 Participants |
| Region of Enrollment United States | 93 Participants | 87 Participants | 180 Participants |
| Screening BMI | 25.12 kg/m2 STANDARD_DEVIATION 3.029 | 25.32 kg/m2 STANDARD_DEVIATION 2.947 | 25.22 kg/m2 STANDARD_DEVIATION 2.983 |
| Screening height | 168.35 cm STANDARD_DEVIATION 9.266 | 169.57 cm STANDARD_DEVIATION 9.795 | 168.94 cm STANDARD_DEVIATION 9.518 |
| Screening weight | 71.61 kg STANDARD_DEVIATION 12.888 | 73.12 kg STANDARD_DEVIATION 12.574 | 72.34 kg STANDARD_DEVIATION 12.725 |
| Sex: Female, Male Female | 45 Participants | 45 Participants | 90 Participants |
| Sex: Female, Male Male | 48 Participants | 42 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 87 |
| other Total, other adverse events | 55 / 93 | 45 / 87 |
| serious Total, serious adverse events | 2 / 93 | 0 / 87 |
Outcome results
Primary
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf)
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population; AUC0-inf PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf) | 2819.5 h•μg/mL | Standard Deviation 945.82 |
| Pre-filled Syringe | Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf) | 2684.5 h•μg/mL | Standard Deviation 1031.16 |
Comparison: Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS90% CI: [93.98, 114.29]ANCOVA
Primary
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last))
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last)) | 2451.3 h•μg/mL | Standard Deviation 1086.28 |
| Pre-filled Syringe | Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last)) | 2292.9 h•μg/mL | Standard Deviation 1026.99 |
Comparison: Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS90% CI: [91.09, 121.86]ANCOVA
Primary
Peak Plasma Concentration (Cmax)
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Peak Plasma Concentration (Cmax) | 4.141 μg/mL | Standard Deviation 1.5479 |
| Pre-filled Syringe | Peak Plasma Concentration (Cmax) | 3.908 μg/mL | Standard Deviation 1.262 |
Comparison: Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS90% CI: [94.08, 111.9]ANCOVA
Secondary
Apparent Total Body Clearance (CL/F)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population; CL/F PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Apparent Total Body Clearance (CL/F) | 0.016 L/h | Standard Deviation 0.0074 |
| Pre-filled Syringe | Apparent Total Body Clearance (CL/F) | 0.017 L/h | Standard Deviation 0.00599 |
Secondary
Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population; Vz/F PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F) | 7.9 L | Standard Deviation 2.75 |
| Pre-filled Syringe | Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F) | 7.9 L | Standard Deviation 2.71 |
Secondary
Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population; %AUCextrap PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap) | 7.3 % of AUCextrap | Standard Deviation 4.52 |
| Pre-filled Syringe | Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap) | 7.1 % of AUCextrap | Standard Deviation 4.52 |
Secondary
Summary of Immunogenicity Assay
To evaluate immunogenicity of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, Days 15, 29, 57, 71 postdose
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Auto Injector | Summary of Immunogenicity Assay | End-of-study NAb | Negative | 14 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Baseline (Day 1 predose) ADA | Positive | 10 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Baseline (Day 1 predose) ADA | Negative | 83 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Baseline (Day 1 predose) ADA | Missing or not applicable | 0 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 15 ADA | Positive | 62 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 15 ADA | Negative | 30 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 15 ADA | Missing or not applicable | 1 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 29 ADA | Positive | 78 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 29 ADA | Negative | 10 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 29 ADA | Missing or not applicable | 5 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 57 ADA | Positive | 82 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 57 ADA | Negative | 6 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 57 ADA | Missing or not applicable | 5 Participants |
| Auto Injector | Summary of Immunogenicity Assay | End-of-study ADA | Positive | 87 Participants |
| Auto Injector | Summary of Immunogenicity Assay | End-of-study ADA | Negative | 4 Participants |
| Auto Injector | Summary of Immunogenicity Assay | End-of-study ADA | Missing or not applicable | 2 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Baseline (Day 1 predose) NAb | Positive | 0 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Baseline (Day 1 predose) NAb | Negative | 10 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Baseline (Day 1 predose) NAb | Missing or not applicable | 83 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 15 NAb | Positive | 21 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 15 NAb | Negative | 41 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 15 NAb | Missing or not applicable | 31 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 29 NAb | Positive | 39 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 29 NAb | Negative | 39 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 29 NAb | Missing or not applicable | 15 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 57 NAb | Positive | 65 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 57 NAb | Negative | 17 Participants |
| Auto Injector | Summary of Immunogenicity Assay | Day 57 NAb | Missing or not applicable | 11 Participants |
| Auto Injector | Summary of Immunogenicity Assay | End-of-study NAb | Positive | 73 Participants |
| Auto Injector | Summary of Immunogenicity Assay | End-of-study NAb | Missing or not applicable | 6 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | End-of-study ADA | Missing or not applicable | 3 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 29 NAb | Negative | 29 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Baseline (Day 1 predose) ADA | Positive | 5 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Baseline (Day 1 predose) NAb | Positive | 0 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Baseline (Day 1 predose) ADA | Negative | 82 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 57 NAb | Missing or not applicable | 14 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Baseline (Day 1 predose) ADA | Missing or not applicable | 0 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Baseline (Day 1 predose) NAb | Negative | 5 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 15 ADA | Positive | 59 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 15 ADA | Missing or not applicable | 1 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 29 NAb | Missing or not applicable | 14 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 15 ADA | Negative | 27 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Baseline (Day 1 predose) NAb | Missing or not applicable | 82 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | End-of-study NAb | Missing or not applicable | 9 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 29 ADA | Positive | 73 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 15 NAb | Positive | 25 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 29 ADA | Negative | 11 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 57 NAb | Positive | 60 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 29 ADA | Missing or not applicable | 3 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 15 NAb | Negative | 34 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 57 ADA | Positive | 73 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | End-of-study NAb | Positive | 68 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 57 ADA | Negative | 7 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 15 NAb | Missing or not applicable | 28 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 57 ADA | Missing or not applicable | 7 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 57 NAb | Negative | 13 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | End-of-study ADA | Positive | 78 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | Day 29 NAb | Positive | 44 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | End-of-study ADA | Negative | 6 Participants |
| Pre-filled Syringe | Summary of Immunogenicity Assay | End-of-study NAb | Negative | 10 Participants |
Secondary
Terminal Elimination Half-life (t1/2)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population; t1/2 PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Terminal Elimination Half-life (t1/2) | 369.0 hour | Standard Deviation 139.76 |
| Pre-filled Syringe | Terminal Elimination Half-life (t1/2) | 355.4 hour | Standard Deviation 141.8 |
Secondary
Terminal Elimination Rate Constant (λz)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population; λz PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto Injector | Terminal Elimination Rate Constant (λz) | 0.0022 1/h | Standard Deviation 0.0011 |
| Pre-filled Syringe | Terminal Elimination Rate Constant (λz) | 0.0023 1/h | Standard Deviation 0.001 |
Secondary
Time to Maximum Serum Concentration (Tmax)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Population: Pharmacokinetics population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auto Injector | Time to Maximum Serum Concentration (Tmax) | 132 hour |
| Pre-filled Syringe | Time to Maximum Serum Concentration (Tmax) | 132 hour |