Trial Outcomes & Findings for Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects (NCT NCT01922336)
NCT ID: NCT01922336
Last Updated: 2019-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
159 participants
Primary outcome timeframe
71 days
Results posted on
2019-02-21
Participant Flow
Participant milestones
| Measure |
SB2 (Proposed Infliximab Biosimilar)
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
53
|
|
Overall Study
COMPLETED
|
53
|
53
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=53 Participants
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 Participants
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 Participants
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 9.87 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 9.71 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
BMI
|
24.56 kg/m2
STANDARD_DEVIATION 2.078 • n=5 Participants
|
25.39 kg/m2
STANDARD_DEVIATION 2.092 • n=7 Participants
|
24.79 kg/m2
STANDARD_DEVIATION 2.058 • n=5 Participants
|
24.91 kg/m2
STANDARD_DEVIATION 2.092 • n=4 Participants
|
PRIMARY outcome
Timeframe: 71 daysOutcome measures
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=51 Participants
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 Participants
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 Participants
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
38702.8145 h·μg/mL
Standard Deviation 11113.62172
|
39359.7493 h·μg/mL
Standard Deviation 12332.41615
|
39270.1707 h·μg/mL
Standard Deviation 10064.08853
|
PRIMARY outcome
Timeframe: 71 daysOutcome measures
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=51 Participants
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 Participants
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 Participants
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
126.9975 μg/mL
Standard Deviation 16.89586
|
126.2377 μg/mL
Standard Deviation 17.88151
|
129.1508 μg/mL
Standard Deviation 18.75573
|
PRIMARY outcome
Timeframe: 71 daysOutcome measures
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=51 Participants
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 Participants
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 Participants
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
36862.4180 h·μg/mL
Standard Deviation 9132.75342
|
37022.3524 h·μg/mL
Standard Deviation 9398.42182
|
37367.5577 h·μg/mL
Standard Deviation 8332.05331
|
SECONDARY outcome
Timeframe: 71 daysOutcome measures
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=51 Participants
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 Participants
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 Participants
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Time to Cmax (Tmax)
|
2.9294 hour
Standard Deviation 1.11529
|
2.5824 hour
Standard Deviation 0.95950
|
2.7591 hour
Standard Deviation 1.03184
|
Adverse Events
SB2 (Proposed Infliximab Biosimilar)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
EU Remicade
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
US Remicade
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=53 participants at risk
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 participants at risk
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 participants at risk
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Infections and infestations
Borrelia infection
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Concussion
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
|
Renal and urinary disorders
Renal cyst ruptured
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
0.00%
0/53
|
Other adverse events
| Measure |
SB2 (Proposed Infliximab Biosimilar)
n=53 participants at risk
SB2 (Study drug)
SB2: IV infusion
|
EU Remicade
n=53 participants at risk
EU sourced Remicade (Reference drug)
EU Remicade: IV infusion
|
US Remicade
n=53 participants at risk
US sourced Remicade (Reference drug)
US Remicade: IV infusion
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.3%
6/53 • Number of events 6
|
7.5%
4/53 • Number of events 4
|
24.5%
13/53 • Number of events 13
|
|
Nervous system disorders
Headache
|
9.4%
5/53 • Number of events 9
|
11.3%
6/53 • Number of events 8
|
13.2%
7/53 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
3/53 • Number of events 3
|
3.8%
2/53 • Number of events 2
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
5.7%
3/53 • Number of events 3
|
3.8%
2/53 • Number of events 2
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
3/53 • Number of events 3
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
Additional Information
Director of Clinical Trials
Samsung Bioepis Co., Ltd.
Phone: +82 31 8061 4534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place