Trial Outcomes & Findings for Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects (NCT NCT02144714)
NCT ID: NCT02144714
Last Updated: 2018-11-14
Results Overview
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
189 participants
Primary outcome timeframe
0 to 1680 hours post-dose
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
63
|
|
Overall Study
COMPLETED
|
63
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=63 Participants
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=63 Participants
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=63 Participants
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 10.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Height (cm)
|
177.8 cm
STANDARD_DEVIATION 6.72 • n=5 Participants
|
177.5 cm
STANDARD_DEVIATION 6.34 • n=7 Participants
|
177.0 cm
STANDARD_DEVIATION 6.68 • n=5 Participants
|
177.4 cm
STANDARD_DEVIATION 6.56 • n=4 Participants
|
|
Weight (kg)
|
78.83 kg
STANDARD_DEVIATION 7.163 • n=5 Participants
|
78.19 kg
STANDARD_DEVIATION 6.388 • n=7 Participants
|
78.12 kg
STANDARD_DEVIATION 6.458 • n=5 Participants
|
78.38 kg
STANDARD_DEVIATION 6.651 • n=4 Participants
|
|
BMI (kg/m^2)
|
24.98 kg/m^2
STANDARD_DEVIATION 2.301 • n=5 Participants
|
24.82 kg/m^2
STANDARD_DEVIATION 1.823 • n=7 Participants
|
24.97 kg/m^2
STANDARD_DEVIATION 1.959 • n=5 Participants
|
24.93 kg/m^2
STANDARD_DEVIATION 2.028 • n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 1680 hours post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Outcome measures
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=53 Participants
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=61 Participants
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=57 Participants
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
2405.6 μg·h/mL
Standard Deviation 825.93
|
2435.5 μg·h/mL
Standard Deviation 915.66
|
2422.6 μg·h/mL
Standard Deviation 957.00
|
PRIMARY outcome
Timeframe: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Outcome measures
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=53 Participants
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=61 Participants
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=57 Participants
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
3.365 μg/mL
Standard Deviation 0.9796
|
3.548 μg/mL
Standard Deviation 1.1811
|
3.488 μg/mL
Standard Deviation 1.0779
|
PRIMARY outcome
Timeframe: 0 to 1680 hours post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Outcome measures
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=53 Participants
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=61 Participants
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=57 Participants
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
2125.7 μg·h/mL
Standard Deviation 689.92
|
2096.0 μg·h/mL
Standard Deviation 791.28
|
2101.9 μg·h/mL
Standard Deviation 795.56
|
SECONDARY outcome
Timeframe: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Outcome measures
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=53 Participants
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=61 Participants
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=57 Participants
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Time to Cmax (Tmax)
|
165.962 h
Standard Deviation 89.2503
|
149.715 h
Standard Deviation 76.6421
|
166.456 h
Standard Deviation 79.9227
|
Adverse Events
SB5 (Proposed Adalimumab Biosimilar)
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
EU Sourced Humira®
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
US Sourced Humira®
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=63 participants at risk
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=63 participants at risk
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=63 participants at risk
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/63 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
0.00%
0/63 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
1.6%
1/63 • Number of events 1 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
1/63 • Number of events 1 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
0.00%
0/63 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
0.00%
0/63 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
Other adverse events
| Measure |
SB5 (Proposed Adalimumab Biosimilar)
n=63 participants at risk
SB5, single dose of 40 mg via subcutaneous injection (study drug)
SB5
EU sourced Humira®
|
EU Sourced Humira®
n=63 participants at risk
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5
US sourced Humira®
|
US Sourced Humira®
n=63 participants at risk
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®
US sourced Humira®
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.0%
12/63 • Number of events 12 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
12.7%
8/63 • Number of events 8 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
17.5%
11/63 • Number of events 11 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
|
Infections and infestations
Oral herpes
|
6.3%
4/63 • Number of events 4 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
1.6%
1/63 • Number of events 1 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
6.3%
4/63 • Number of events 4 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
|
Infections and infestations
Rhinitis
|
3.2%
2/63 • Number of events 2 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
6.3%
4/63 • Number of events 4 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
4.8%
3/63 • Number of events 3 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
|
Nervous system disorders
Headache
|
17.5%
11/63 • Number of events 15 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
6.3%
4/63 • Number of events 4 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
11.1%
7/63 • Number of events 7 • The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place