To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04295356
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 37.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: CT-P17; Biological: CT-P17	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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-P17 in Healthy Subjects
• Actual Study Start Date: Jun 21, 2019
• Actual Primary Completion Date: Nov 15, 2019
• Actual Study Completion Date: Nov 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Auto injector a single dose (40 mg) of CT-P17 via AI	Biological: CT-P17; subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
Active Comparator: Pre-filled syringe a single dose (40 mg) of CT-P17 via PFS	Biological: CT-P17; subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. 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.

2. BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth.

3. 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).

1. Subject is considered to have a significant abnormal cardiac function in investigator's discretion determined by the laboratory results.

2. 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.

3. 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.

4. 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).

5. Male subject is planning to father a child or donate sperm within 5 months after the administration of the study drug (Day 1).

6. 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).

7. 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).

8. 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.

9. 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

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

• Celltrion

Investigators

• Study Director: Sung Hyun Kim, Dr, Celltrion

Study Documents (Full-Text)

• Study Protocol - Jun 27, 2019
• Statistical Analysis Plan - Dec 9, 2019

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT04295356
• Other Study ID Numbers: CT-P17 1.3
• First Posted: Mar 4, 2020
• Last Update Posted: Jan 19, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	93	87
COMPLETED	92	83
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Auto Injector	Pre-filled Syringe	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	93	87	180
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	35.2	36.7	35.9
Sex: Female, Male (Count of Participants)
Female	45 48.4%	45 51.7%	90 50%
Male	48 51.6%	42 48.3%	90 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	32 34.4%	25 28.7%	57 31.7%
Not Hispanic or Latino	61 65.6%	62 71.3%	123 68.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.1%	0 0%	1 0.6%
Asian	3 3.2%	1 1.1%	4 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	34 36.6%	39 44.8%	73 40.6%
White	53 57%	47 54%	100 55.6%
More than one race	2 2.2%	0 0%	2 1.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	93 100%	87 100%	180 100%
Female fertility status (Count of Participants)
Surgically sterilized	10 10.8%	9 10.3%	19 10.6%
Post-menopausal	3 3.2%	0 0%	3 1.7%
Potentially able to bear children	32 34.4%	36 41.4%	68 37.8%
Not applicable (male)	48 51.6%	42 48.3%	90 50%
Screening height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	168.35 (9.266)	169.57 (9.795)	168.94 (9.518)
Screening weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	71.61 (12.888)	73.12 (12.574)	72.34 (12.725)
Screening BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	25.12 (3.029)	25.32 (2.947)	25.22 (2.983)
Day -1 BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	25.26 (2.967)	25.50 (2.939)	25.38 (2.948)
Day -1 weight category (Count of Participants)
Weight <80 kg	65 69.9%	62 71.3%	127 70.6%
Weight ≥80 kg	28 30.1%	25 28.7%	53 29.4%

Outcome Measures

1. Primary Outcome

Title	Peak Plasma Concentration (Cmax)
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetics population

Arm/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	84	76
Mean (Standard Deviation) [μg/mL]	4.141 (1.5479)	3.908 (1.2620)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Auto Injector, Pre-filled Syringe
	Comments	Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS
	Type of Statistical Test	Equivalence
	Comments	The 90% confidence interval of the ratio of geometric least squares means of Cmax was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric least squares means
	Estimated Value	102.60
	Confidence Interval	(2-Sided) 90%; 94.08 to 111.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	69	63
Mean (Standard Deviation) [h•μg/mL]	2819.5 (945.82)	2684.5 (1031.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Auto Injector, Pre-filled Syringe
	Comments	Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS
	Type of Statistical Test	Equivalence
	Comments	The 90% confidence interval of the ratio of geometric least squares means of AUC0-inf was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric least squares means
	Estimated Value	103.64
	Confidence Interval	(2-Sided) 90%; 93.98 to 114.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last))
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetics population

Arm/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	84	76
Mean (Standard Deviation) [h•μg/mL]	2451.3 (1086.28)	2292.9 (1026.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Auto Injector, Pre-filled Syringe
	Comments	Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS
	Type of Statistical Test	Equivalence
	Comments	The 90% confidence interval of the ratio of geometric least squares means of AUC0-last was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric least squares means
	Estimated Value	105.36
	Confidence Interval	(2-Sided) 90%; 91.09 to 121.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Time to Maximum Serum Concentration (Tmax)
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetics population

Arm/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	84	76
Median (Full Range) [hour]	132	132

5. Secondary Outcome

Title	Terminal Elimination Half-life (t1/2)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	69	63
Mean (Standard Deviation) [hour]	369.0 (139.76)	355.4 (141.80)

6. Secondary Outcome

Title	Terminal Elimination Rate Constant (λz)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	69	63
Mean (Standard Deviation) [1/h]	0.0022 (0.00110)	0.0023 (0.00100)

7. Secondary Outcome

Title	Apparent Total Body Clearance (CL/F)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	69	63
Mean (Standard Deviation) [L/h]	0.016 (0.00740)	0.017 (0.00599)

8. Secondary Outcome

Title	Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	69	63
Mean (Standard Deviation) [L]	7.9 (2.75)	7.9 (2.71)

9. Secondary Outcome

Title	Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	69	63
Mean (Standard Deviation) [% of AUCextrap]	7.3 (4.52)	7.1 (4.52)

10. Secondary Outcome

Title	Summary of Immunogenicity Assay
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Auto Injector	Pre-filled Syringe
Arm/Group Description	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	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
Measure Participants	93	87
Positive	10 10.8%	5 5.7%
Negative	83 89.2%	82 94.3%
Missing or not applicable	0 0%	0 0%
Positive	62 66.7%	59 67.8%
Negative	30 32.3%	27 31%
Missing or not applicable	1 1.1%	1 1.1%
Positive	78 83.9%	73 83.9%
Negative	10 10.8%	11 12.6%
Missing or not applicable	5 5.4%	3 3.4%
Positive	82 88.2%	73 83.9%
Negative	6 6.5%	7 8%
Missing or not applicable	5 5.4%	7 8%
Positive	87 93.5%	78 89.7%
Negative	4 4.3%	6 6.9%
Missing or not applicable	2 2.2%	3 3.4%
Positive	0 0%	0 0%
Negative	10 10.8%	5 5.7%
Missing or not applicable	83 89.2%	82 94.3%
Positive	21 22.6%	25 28.7%
Negative	41 44.1%	34 39.1%
Missing or not applicable	31 33.3%	28 32.2%
Positive	39 41.9%	44 50.6%
Negative	39 41.9%	29 33.3%
Missing or not applicable	15 16.1%	14 16.1%
Positive	65 69.9%	60 69%
Negative	17 18.3%	13 14.9%
Missing or not applicable	11 11.8%	14 16.1%
Positive	73 78.5%	68 78.2%
Negative	14 15.1%	10 11.5%
Missing or not applicable	6 6.5%	9 10.3%

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Auto Injector		Pre-filled Syringe
Arm/Group Description	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		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
All Cause Mortality
	Auto Injector		Pre-filled Syringe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		0/87 (0%)
Serious Adverse Events
	Auto Injector		Pre-filled Syringe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/93 (2.2%)		0/87 (0%)
Infections and infestations
Viral meningitis	1/93 (1.1%)		0/87 (0%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	1/93 (1.1%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	Auto Injector		Pre-filled Syringe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/93 (59.1%)		45/87 (51.7%)
Blood and lymphatic system disorders
Leukocytosis	1/93 (1.1%)		0/87 (0%)
Lymphadenopathy	1/93 (1.1%)		0/87 (0%)
Cardiac disorders
Palpitations	0/93 (0%)		1/87 (1.1%)
Ear and labyrinth disorders
Ear pain	0/93 (0%)		1/87 (1.1%)
Eye disorders
Eyelid irritation	0/93 (0%)		2/87 (2.3%)
Vision blurred	1/93 (1.1%)		0/87 (0%)
Gastrointestinal disorders
Abdominal discomfort	2/93 (2.2%)		1/87 (1.1%)
Abdominal distension	1/93 (1.1%)		0/87 (0%)
Abdominal pain	1/93 (1.1%)		0/87 (0%)
Abdominal pain upper	1/93 (1.1%)		0/87 (0%)
Constipation	4/93 (4.3%)		2/87 (2.3%)
Dental caries	0/93 (0%)		1/87 (1.1%)
Diarrhoea	1/93 (1.1%)		0/87 (0%)
Dry mouth	1/93 (1.1%)		0/87 (0%)
Infrequent bowel movements	0/93 (0%)		1/87 (1.1%)
Nausea	0/93 (0%)		3/87 (3.4%)
Toothache	1/93 (1.1%)		2/87 (2.3%)
Vomiting	1/93 (1.1%)		1/87 (1.1%)
General disorders
Chills	1/93 (1.1%)		1/87 (1.1%)
Fatigue	1/93 (1.1%)		2/87 (2.3%)
Feeling hot	1/93 (1.1%)		0/87 (0%)
Injection site reaction	8/93 (8.6%)		6/87 (6.9%)
Oedema peripheral	1/93 (1.1%)		0/87 (0%)
Pyrexia	0/93 (0%)		1/87 (1.1%)
Immune system disorders
Hypersensitivity	3/93 (3.2%)		1/87 (1.1%)
Infections and infestations
Cystitis	0/93 (0%)		1/87 (1.1%)
Nasopharyngitis	1/93 (1.1%)		0/87 (0%)
Pyuria	1/93 (1.1%)		0/87 (0%)
Subcutaneous abscess	1/93 (1.1%)		0/87 (0%)
Upper respiratory tract infection	3/93 (3.2%)		2/87 (2.3%)
Urinary tract infection	3/93 (3.2%)		2/87 (2.3%)
Vaginal infection	1/93 (1.1%)		0/87 (0%)
Vulvovaginal mycotic infection	0/93 (0%)		1/87 (1.1%)
Injury, poisoning and procedural complications
Arthropod bite	2/93 (2.2%)		0/87 (0%)
Head injury	0/93 (0%)		1/87 (1.1%)
Joint injury	2/93 (2.2%)		0/87 (0%)
Scratch	0/93 (0%)		1/87 (1.1%)
Skin abrasion	0/93 (0%)		1/87 (1.1%)
Skin laceration	1/93 (1.1%)		0/87 (0%)
Investigations
Alanine aminotransferase increased	3/93 (3.2%)		2/87 (2.3%)
Aspartate aminotransferase increased	1/93 (1.1%)		0/87 (0%)
Blood bilirubin increased	0/93 (0%)		3/87 (3.4%)
Blood creatine phosphokinase MB increased	1/93 (1.1%)		0/87 (0%)
Blood creatine phosphokinase increased	7/93 (7.5%)		4/87 (4.6%)
Blood lactate dehydrogenase increased	1/93 (1.1%)		0/87 (0%)
C-reactive protein increased	5/93 (5.4%)		5/87 (5.7%)
Electrocardiogram T-wave abnormal	0/93 (0%)		1/87 (1.1%)
Haematocrit decreased	1/93 (1.1%)		0/87 (0%)
Haemoglobin decreased	1/93 (1.1%)		0/87 (0%)
Hepatic enzyme increased	1/93 (1.1%)		1/87 (1.1%)
Urine output decreased	1/93 (1.1%)		0/87 (0%)
White blood cell count increased	0/93 (0%)		1/87 (1.1%)
Metabolism and nutrition disorders
Decreased appetite	0/93 (0%)		1/87 (1.1%)
Dyslipidaemia	8/93 (8.6%)		5/87 (5.7%)
Hypertriglyceridaemia	0/93 (0%)		1/87 (1.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/93 (4.3%)		0/87 (0%)
Back pain	4/93 (4.3%)		1/87 (1.1%)
Muscle twitching	1/93 (1.1%)		0/87 (0%)
Musculoskeletal chest pain	0/93 (0%)		1/87 (1.1%)
Musculoskeletal pain	7/93 (7.5%)		1/87 (1.1%)
Myalgia	2/93 (2.2%)		0/87 (0%)
Nervous system disorders
Aura	1/93 (1.1%)		0/87 (0%)
Dizziness	0/93 (0%)		2/87 (2.3%)
Dysgeusia	0/93 (0%)		1/87 (1.1%)
Headache	11/93 (11.8%)		8/87 (9.2%)
Paraesthesia	1/93 (1.1%)		1/87 (1.1%)
Psychiatric disorders
Insomnia	0/93 (0%)		1/87 (1.1%)
Renal and urinary disorders
Dysuria	1/93 (1.1%)		0/87 (0%)
Haematuria	2/93 (2.2%)		2/87 (2.3%)
Nephrolithiasis	1/93 (1.1%)		0/87 (0%)
Reproductive system and breast disorders
Menorrhagia	1/93 (1.1%)		0/87 (0%)
Metrorrhagia	0/93 (0%)		1/87 (1.1%)
Vulvovaginal discomfort	1/93 (1.1%)		0/87 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/93 (1.1%)		3/87 (3.4%)
Dyspnoea	0/93 (0%)		1/87 (1.1%)
Nasal congestion	2/93 (2.2%)		2/87 (2.3%)
Oropharyngeal pain	2/93 (2.2%)		1/87 (1.1%)
Rhinitis allergic	0/93 (0%)		1/87 (1.1%)
Rhinorrhoea	1/93 (1.1%)		2/87 (2.3%)
Skin and subcutaneous tissue disorders
Dermatitis	1/93 (1.1%)		2/87 (2.3%)
Erythema	0/93 (0%)		1/87 (1.1%)
Macule	1/93 (1.1%)		0/87 (0%)
Night sweats	0/93 (0%)		1/87 (1.1%)
Skin irritation	0/93 (0%)		1/87 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.