Trial Outcomes & Findings for Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects (NCT NCT02075073)
NCT ID: NCT02075073
Last Updated: 2017-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
109 participants
Primary outcome timeframe
57 days
Results posted on
2017-09-14
Participant Flow
Participant milestones
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 Participants
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=37 Participants
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 Participants
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 10.80 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 10.75 • 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
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 57 daysOutcome measures
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 Participants
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=36 Participants
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 Participants
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
34783.4 µg·h/mL
Standard Deviation 5614.13
|
35889.9 µg·h/mL
Standard Deviation 5761.37
|
37370.3 µg·h/mL
Standard Deviation 5620.05
|
PRIMARY outcome
Timeframe: 57 daysOutcome measures
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 Participants
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=36 Participants
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 Participants
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
154.224 µg/mL
Standard Deviation 28.0068
|
153.479 µg/mL
Standard Deviation 24.7249
|
155.513 µg/mL
Standard Deviation 25.5812
|
PRIMARY outcome
Timeframe: 57 daysOutcome measures
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 Participants
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=36 Participants
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 Participants
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
34320.8 µg·h/mL
Standard Deviation 5349.12
|
35367.5 µg·h/mL
Standard Deviation 5524.09
|
36690.4 µg·h/mL
Standard Deviation 5341.68
|
SECONDARY outcome
Timeframe: 57 daysOutcome measures
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 Participants
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=36 Participants
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 Participants
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Time to Cmax (Tmax)
|
4.691 hour
Standard Deviation 15.6597
|
3.529 hour
Standard Deviation 7.6948
|
2.799 hour
Standard Deviation 3.7569
|
Adverse Events
SB3 (Proposed Trastuzumab Biosimilar)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
EU Sourced Herceptin®
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
US Sourced Herceptin®
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 participants at risk
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=36 participants at risk
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 participants at risk
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
Other adverse events
| Measure |
SB3 (Proposed Trastuzumab Biosimilar)
n=36 participants at risk
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3
|
EU Sourced Herceptin®
n=36 participants at risk
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®
|
US Sourced Herceptin®
n=36 participants at risk
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Haematoma
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Cardiac disorders
Tachycardia
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Cardiac disorders
Palpitations
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 3
|
|
Ear and labyrinth disorders
Ear pain
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Eye disorders
Dry eye
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/36
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
2/36 • Number of events 3
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Gastrointestinal disorders
Gastric disorder
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Fatigue
|
8.3%
3/36 • Number of events 4
|
2.8%
1/36 • Number of events 1
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Chills
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
General disorders
Pyrexia
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
4/36 • Number of events 4
|
11.1%
4/36 • Number of events 4
|
22.2%
8/36 • Number of events 8
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
2/36 • Number of events 2
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
Rhinitis
|
5.6%
2/36 • Number of events 3
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Oral herpes
|
5.6%
2/36 • Number of events 2
|
8.3%
3/36 • Number of events 3
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Viral infection
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Infections and infestations
Hordeolum
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
9/36 • Number of events 9
|
22.2%
8/36 • Number of events 8
|
44.4%
16/36 • Number of events 16
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • Number of events 3
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
8.3%
3/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Headache
|
25.0%
9/36 • Number of events 12
|
11.1%
4/36 • Number of events 4
|
13.9%
5/36 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
0.00%
0/36
|
|
Nervous system disorders
Disturbance in attention
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Nervous system disorders
Sciatica
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Nervous system disorders
Somnolence
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/36
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
4/36 • Number of events 6
|
0.00%
0/36
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
Additional Information
Director, Clinical Development
Samsung Bioepis
Phone: +82 31 8061 4534
Results disclosure agreements
- Principal investigator is a sponsor employee Project results may not be published or referred to, in whole or in part, by the Service Provider or any of its Affiliates without the prior expressed written consent of Sponsor, which will not be unreasonably withheld or delayed. Neither Party shall use the other Party's name in connection with any publication or promotion without the other Party's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER