Trial Outcomes & Findings for Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects (NCT NCT02453672)
NCT ID: NCT02453672
Last Updated: 2019-06-03
Results Overview
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
119 participants
Primary outcome timeframe
0 to 2016 hours after start of infusion
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
39
|
|
Overall Study
COMPLETED
|
37
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=40 Participants
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=40 Participants
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=39 Participants
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 10.45 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 9.90 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 2016 hours after start of infusionPopulation: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Outcome measures
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=38 Participants
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=38 Participants
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=38 Participants
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
25354.4 h·μg/mL
Standard Deviation 4833.10
|
28896.8 h·μg/mL
Standard Deviation 6221.62
|
28684.8 h·μg/mL
Standard Deviation 5425.14
|
PRIMARY outcome
Timeframe: 0 to 2016 hours after start of infusionPopulation: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Outcome measures
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=38 Participants
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=38 Participants
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=38 Participants
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
24199.2 h·μg/mL
Standard Deviation 4367.53
|
27342.2 h·μg/mL
Standard Deviation 5374.53
|
27177.9 h·μg/mL
Standard Deviation 4770.93
|
PRIMARY outcome
Timeframe: 0 to 2016 hours after start of infusionPopulation: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Outcome measures
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=38 Participants
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=38 Participants
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=38 Participants
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
76.259 μg/mL
Standard Deviation 14.6999
|
76.059 μg/mL
Standard Deviation 11.7053
|
76.485 μg/mL
Standard Deviation 16.9916
|
SECONDARY outcome
Timeframe: 0 to 2016 hours after start of infusionPopulation: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.
0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.
Outcome measures
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=38 Participants
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=38 Participants
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=38 Participants
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax)
|
3.639 h
Standard Deviation 2.1885
|
3.638 h
Standard Deviation 2.4261
|
5.646 h
Standard Deviation 15.6665
|
Adverse Events
SB8 (Proposed Bevacizumab Biosimilar)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
EU Sourced Avastin®
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
US Sourced Avastin®
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=40 participants at risk
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=40 participants at risk
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=39 participants at risk
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Infections and infestations
Perirectal abscess
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
Other adverse events
| Measure |
SB8 (Proposed Bevacizumab Biosimilar)
n=40 participants at risk
SB8, single dose of 3 mg/kg, IV infusion
SB8: SB8, proposed bevacizumab biosimilar
|
EU Sourced Avastin®
n=40 participants at risk
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
US Sourced Avastin®
n=39 participants at risk
US Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
4/40 • 12 weeks
|
5.0%
2/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
2/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
General disorders
Influenza like illness
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
General disorders
Fatigue
|
0.00%
0/40 • 12 weeks
|
5.0%
2/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
General disorders
Catheter site pain
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
General disorders
Chest pain
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • 12 weeks
|
15.0%
6/40 • 12 weeks
|
15.4%
6/39 • 12 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
5.1%
2/39 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
17.9%
7/39 • 12 weeks
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
2/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
5.1%
2/39 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • 12 weeks
|
0.00%
0/40 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/40 • 12 weeks
|
2.5%
1/40 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place