Trial Outcomes & Findings for To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin (NCT NCT03247673)
NCT ID: NCT03247673
Last Updated: 2020-03-26
Results Overview
Area under the concentration-time curve from time zero to infinity
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
141 participants
Primary outcome timeframe
pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Results posted on
2020-03-26
Participant Flow
Participant milestones
| Measure |
CT-P16
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
48
|
|
Overall Study
COMPLETED
|
45
|
47
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
Reasons for withdrawal
| Measure |
CT-P16
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Baseline characteristics by cohort
| Measure |
CT-P16
n=46 Participants
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 Participants
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 Participants
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 8.69 • n=99 Participants
|
28.4 years
STANDARD_DEVIATION 7.59 • n=107 Participants
|
26.5 years
STANDARD_DEVIATION 6.28 • n=206 Participants
|
27.8 years
STANDARD_DEVIATION 7.57 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
46 participants
n=99 Participants
|
47 participants
n=107 Participants
|
48 participants
n=206 Participants
|
141 participants
n=7 Participants
|
|
Weight (kg)
|
69.93 kg
STANDARD_DEVIATION 9.073 • n=99 Participants
|
71.01 kg
STANDARD_DEVIATION 9.417 • n=107 Participants
|
69.54 kg
STANDARD_DEVIATION 8.141 • n=206 Participants
|
70.16 kg
STANDARD_DEVIATION 8.845 • n=7 Participants
|
|
BMI
|
22.89 kg/m^2
STANDARD_DEVIATION 2.310 • n=99 Participants
|
23.20 kg/m^2
STANDARD_DEVIATION 2.492 • n=107 Participants
|
23.17 kg/m^2
STANDARD_DEVIATION 2.303 • n=206 Participants
|
23.09 kg/m^2
STANDARD_DEVIATION 2.357 • n=7 Participants
|
PRIMARY outcome
Timeframe: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOIPopulation: PK population
Area under the concentration-time curve from time zero to infinity
Outcome measures
| Measure |
CT-P16
n=46 Participants
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 Participants
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 Participants
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
AUC0-inf
|
42034.90 h*ug/mL
Standard Deviation 6070.668
|
40413.44 h*ug/mL
Standard Deviation 5012.778
|
43017.95 h*ug/mL
Standard Deviation 5782.951
|
PRIMARY outcome
Timeframe: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOIPopulation: PK population
Maximum Serum Concentration (Cmax)
Outcome measures
| Measure |
CT-P16
n=46 Participants
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 Participants
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 Participants
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
Cmax
|
117.22 ug/mL
Standard Deviation 17.756
|
114.06 ug/mL
Standard Deviation 15.391
|
113.09 ug/mL
Standard Deviation 17.402
|
PRIMARY outcome
Timeframe: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOIPopulation: PK population
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
Outcome measures
| Measure |
CT-P16
n=46 Participants
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 Participants
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 Participants
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
AUC0-last
|
41142.81 h*ug/mL
Standard Deviation 5694.184
|
39411.98 h*ug/mL
Standard Deviation 4649.319
|
41804.05 h*ug/mL
Standard Deviation 5463.814
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOIPopulation: PK population
To assess the additional PK of study drugs (Time to Cmax)
Outcome measures
| Measure |
CT-P16
n=46 Participants
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 Participants
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 Participants
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
Additional Pharmacokinetics (Time to Cmax)
|
2.5 h
Interval 1.5 to 12.0
|
2.5 h
Interval 1.5 to 8.0
|
2.5 h
Interval 1.5 to 8.0
|
SECONDARY outcome
Timeframe: up to 15 weeksPopulation: Safety Population
number of participants with anti-drug antibody positive at post-dose
Outcome measures
| Measure |
CT-P16
n=46 Participants
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 Participants
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 Participants
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
Number of Participants With Anti-Drug Antibody Positive
|
2 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
CT-P16
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
EU-approved Avastin
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
US-licensed Avastin
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CT-P16
n=46 participants at risk
CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects
CT-P16: CT-P16 is a biosimilar product for Avastin
|
EU-approved Avastin
n=47 participants at risk
EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
EU-approved Avastin: EU-approved Avastin
|
US-licensed Avastin
n=48 participants at risk
US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects
US-licensed Avastin: US-licensed Avastin
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46 • up to 15 weeks
|
12.8%
6/47 • up to 15 weeks
|
8.3%
4/48 • up to 15 weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
4/46 • up to 15 weeks
|
2.1%
1/47 • up to 15 weeks
|
12.5%
6/48 • up to 15 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
6.5%
3/46 • up to 15 weeks
|
10.6%
5/47 • up to 15 weeks
|
8.3%
4/48 • up to 15 weeks
|
|
Investigations
C-reactive protein increased
|
4.3%
2/46 • up to 15 weeks
|
10.6%
5/47 • up to 15 weeks
|
8.3%
4/48 • up to 15 weeks
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
4.3%
2/46 • up to 15 weeks
|
4.3%
2/47 • up to 15 weeks
|
8.3%
4/48 • up to 15 weeks
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • up to 15 weeks
|
4.3%
2/47 • up to 15 weeks
|
6.2%
3/48 • up to 15 weeks
|
|
Investigations
Troponin I increased
|
2.2%
1/46 • up to 15 weeks
|
6.4%
3/47 • up to 15 weeks
|
0.00%
0/48 • up to 15 weeks
|
|
Investigations
White blood cell count decreased
|
2.2%
1/46 • up to 15 weeks
|
0.00%
0/47 • up to 15 weeks
|
6.2%
3/48 • up to 15 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER