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Trial Outcomes & Findings for Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male (NCT NCT03083990)

NCT ID: NCT03083990

Last Updated: 2020-11-27

Results Overview

the area under the blood drug concentration time curve form 0 to t (AUC0 - t)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

100 participants

Primary outcome timeframe

60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure
IBI305
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Overall Study
STARTED
50
50
Overall Study
COMPLETED
49
50
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
IBI305
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Overall Study
Adverse Event
1
0

Baseline Characteristics

Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Total
n=98 Participants
Total of all reporting groups
Age, Continuous
Mean (SD)
36.5 years
STANDARD_DEVIATION 8.92 • n=99 Participants
34.0 years
STANDARD_DEVIATION 8.87 • n=107 Participants
35.2 years
STANDARD_DEVIATION 8.94 • n=206 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Male
48 Participants
n=99 Participants
50 Participants
n=107 Participants
98 Participants
n=206 Participants
Race/Ethnicity, Customized
Han
43 Participants
n=99 Participants
45 Participants
n=107 Participants
88 Participants
n=206 Participants
Race/Ethnicity, Customized
Others
5 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants
Region of Enrollment
China
48 Participants
n=99 Participants
50 Participants
n=107 Participants
98 Participants
n=206 Participants
Height
169.7 centimeter
STANDARD_DEVIATION 5.69 • n=99 Participants
169.0 centimeter
STANDARD_DEVIATION 5.12 • n=107 Participants
169.3 centimeter
STANDARD_DEVIATION 5.39 • n=206 Participants
Weight
67.32 kilogram
STANDARD_DEVIATION 7.763 • n=99 Participants
68.42 kilogram
STANDARD_DEVIATION 6.629 • n=107 Participants
67.88 kilogram
STANDARD_DEVIATION 7.191 • n=206 Participants
Body mass index
23.414 kg/m2
STANDARD_DEVIATION 2.739 • n=99 Participants
23.962 kg/m2
STANDARD_DEVIATION 2.040 • n=107 Participants
23.694 kg/m2
STANDARD_DEVIATION 2.412 • n=206 Participants

PRIMARY outcome

Timeframe: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Population: 2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline

the area under the blood drug concentration time curve form 0 to t (AUC0 - t)

Outcome measures

Outcome measures
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
AUC0 - t
19704.2 h*ug/mL
Standard Deviation 18.8
20736.9 h*ug/mL
Standard Deviation 19.1

PRIMARY outcome

Timeframe: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Population: 2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline

the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞)

Outcome measures

Outcome measures
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
AUC0 - ∞
20180.2 h*ug/mL
Standard Deviation 18.6
21281.4 h*ug/mL
Standard Deviation 19.8

SECONDARY outcome

Timeframe: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Population: 2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline

Maximum serum concentration

Outcome measures

Outcome measures
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Cmax
65.3 ug/mL
Standard Deviation 21.0
67.0 ug/mL
Standard Deviation 18.9

SECONDARY outcome

Timeframe: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Population: 2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline

elimination half life

Outcome measures

Outcome measures
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
t1/2
340.2 hour
Standard Deviation 51.1
356.5 hour
Standard Deviation 69.6

SECONDARY outcome

Timeframe: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Population: 2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline

apparent clearance

Outcome measures

Outcome measures
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Clearance Rate
0.151 ml/h/kg
Standard Deviation 0.0296
0.144 ml/h/kg
Standard Deviation 0.0281

SECONDARY outcome

Timeframe: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days

Population: 2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline

apparent volume of distribution(V）

Outcome measures

Outcome measures
Measure
IBI305
n=48 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Apparent Volume of Distribution
73.8 ml/kg
Standard Deviation 15.9
72.3 ml/kg
Standard Deviation 12.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 99 days after administration

Population: All 100 (100%) subjects were included in the NAb-AS (Neutralizing anti-body analysis set)

The analysis of NAb was done by Covance Pharmaceutical R\&D (Shanghai) Co., Ltd. using methodologically validated ECL immunoassay.

Outcome measures

Outcome measures
Measure
IBI305
n=50 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Number of Participants Positive for Nab（Neutralizing Antibody）
Baseline
2 Participants
0 Participants
Number of Participants Positive for Nab（Neutralizing Antibody）
D15
4 Participants
0 Participants
Number of Participants Positive for Nab（Neutralizing Antibody）
D43
2 Participants
0 Participants
Number of Participants Positive for Nab（Neutralizing Antibody）
D71
2 Participants
0 Participants
Number of Participants Positive for Nab（Neutralizing Antibody）
D99
1 Participants
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 99 days after administration

Population: All 100 (100%) subjects were included in the ADA-AS(Anti-drug Antibody Analysis set)

The analysis of ADA was done by Wuxi AppTec (Shanghai) Co., Ltd. using methodologically validated electrochemiluminescence (ECL) immunoassay.

Outcome measures

Outcome measures
Measure
IBI305
n=50 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Number of Participants Positive for Anti-drug Antibodies
Baseline
2 Participants
0 Participants
Number of Participants Positive for Anti-drug Antibodies
D15
4 Participants
0 Participants
Number of Participants Positive for Anti-drug Antibodies
D43
2 Participants
0 Participants
Number of Participants Positive for Anti-drug Antibodies
D71
2 Participants
0 Participants
Number of Participants Positive for Anti-drug Antibodies
D99
1 Participants
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0, D1( immediately after the end of infusion), D1 (4 hrs after the start of infusion), D1, 8 hrs after the start of infusion, D1 (12 hrs after the start of infusion), D2, D3, D5, D8, D15, D22, D29, D43, D57, D64, D71, D85, D99

Population: All 100 (100%) subjects were included in the safety analysis set. Blood pressure of certain timepoint was not collected because of serve adverse event.

Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.

Outcome measures

Outcome measures
Measure
IBI305
n=50 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Systolic Blood Pressure
Baseline
119.6 mmHg
Standard Deviation 8.73
121.4 mmHg
Standard Deviation 8.02
Systolic Blood Pressure
D1, immediately after the end of infusion
113.3 mmHg
Standard Deviation 10.23
114.5 mmHg
Standard Deviation 8.7
Systolic Blood Pressure
D1, 4 hrs after the start of infusion
118.0 mmHg
Standard Deviation 9.60
119.6 mmHg
Standard Deviation 7.87
Systolic Blood Pressure
D1, 8 hrs after the start of infusion
120.4 mmHg
Standard Deviation 9.48
120.3 mmHg
Standard Deviation 8.30
Systolic Blood Pressure
D1, 12 hrs after the start of infusion
119.8 mmHg
Standard Deviation 8.67
123.4 mmHg
Standard Deviation 9.63
Systolic Blood Pressure
D2
119.8 mmHg
Standard Deviation 9.72
121.9 mmHg
Standard Deviation 8.81
Systolic Blood Pressure
D3
120.2 mmHg
Standard Deviation 8.37
123.2 mmHg
Standard Deviation 9.52
Systolic Blood Pressure
D5
120.7 mmHg
Standard Deviation 7.97
121.4 mmHg
Standard Deviation 8.34
Systolic Blood Pressure
D8
118.4 mmHg
Standard Deviation 7.69
122.6 mmHg
Standard Deviation 9.22
Systolic Blood Pressure
D15
118.6 mmHg
Standard Deviation 9.70
118.5 mmHg
Standard Deviation 10.19
Systolic Blood Pressure
D22
121.8 mmHg
Standard Deviation 8.73
122.5 mmHg
Standard Deviation 8.88
Systolic Blood Pressure
D29
121.6 mmHg
Standard Deviation 9.20
123.1 mmHg
Standard Deviation 8.91
Systolic Blood Pressure
D43
119.7 mmHg
Standard Deviation 9.12
121.3 mmHg
Standard Deviation 9.03
Systolic Blood Pressure
D57
118.4 mmHg
Standard Deviation 10.30
122.1 mmHg
Standard Deviation 8.12
Systolic Blood Pressure
D64
119.4 mmHg
Standard Deviation 8.78
120.2 mmHg
Standard Deviation 10.00
Systolic Blood Pressure
D71
118.3 mmHg
Standard Deviation 10.01
119.8 mmHg
Standard Deviation 10.10
Systolic Blood Pressure
D85
115.8 mmHg
Standard Deviation 9.04
120.6 mmHg
Standard Deviation 9.59
Systolic Blood Pressure
D99
118.2 mmHg
Standard Deviation 7.61
118.2 mmHg
Standard Deviation 10.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 0, D1( immediately after the end of infusion), D1 (4 hrs after the start of infusion), D1, 8 hrs after the start of infusion, D1 (12 hrs after the start of infusion), D2, D3, D5, D8, D15, D22, D29, D43, D57, D64, D71, D85, D99

Population: All 100 (100%) subjects were included in the safety analysis set. Blood pressure of certain timepoint was not collected because of serve adverse event.

Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.

Outcome measures

Outcome measures
Measure
IBI305
n=50 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Diastolic Blood Pressure
Baseline
79.2 mmHg
Standard Deviation 8.02
81.4 mmHg
Standard Deviation 5.94
Diastolic Blood Pressure
D1, immediately after the end of infusion
71.8 mmHg
Standard Deviation 7.82
73.7 mmHg
Standard Deviation 6.64
Diastolic Blood Pressure
D1, 4 hrs after the start of infusion
75.5 mmHg
Standard Deviation 6.68
77.4 mmHg
Standard Deviation 7.13
Diastolic Blood Pressure
D1, 8 hrs after the start of infusion
77.8 mmHg
Standard Deviation 5.94
79.3 mmHg
Standard Deviation 6.95
Diastolic Blood Pressure
D1, 12 hrs after the start of infusion
77.0 mmHg
Standard Deviation 6.96
81.3 mmHg
Standard Deviation 7.37
Diastolic Blood Pressure
D2
79.8 mmHg
Standard Deviation 6.57
81.6 mmHg
Standard Deviation 6.46
Diastolic Blood Pressure
D3
80.5 mmHg
Standard Deviation 6.45
82.8 mmHg
Standard Deviation 6.17
Diastolic Blood Pressure
D5
80.4 mmHg
Standard Deviation 8.30
82.1 mmHg
Standard Deviation 4.71
Diastolic Blood Pressure
D8
78.2 mmHg
Standard Deviation 6.23
81.4 mmHg
Standard Deviation 6.62
Diastolic Blood Pressure
D15
78.2 mmHg
Standard Deviation 7.67
79.2 mmHg
Standard Deviation 6.50
Diastolic Blood Pressure
D22
80.5 mmHg
Standard Deviation 6.04
82.3 mmHg
Standard Deviation 7.47
Diastolic Blood Pressure
D29
79.6 mmHg
Standard Deviation 6.43
81.6 mmHg
Standard Deviation 7.02
Diastolic Blood Pressure
D43
79.5 mmHg
Standard Deviation 7.34
80.0 mmHg
Standard Deviation 6.96
Diastolic Blood Pressure
D57
78.6 mmHg
Standard Deviation 7.87
82.2 mmHg
Standard Deviation 6.18
Diastolic Blood Pressure
D64
78.7 mmHg
Standard Deviation 7.33
80.5 mmHg
Standard Deviation 6.18
Diastolic Blood Pressure
D71
77.1 mmHg
Standard Deviation 8.01
80.2 mmHg
Standard Deviation 6.32
Diastolic Blood Pressure
D85
79.2 mmHg
Standard Deviation 6.96
80.0 mmHg
Standard Deviation 6.42
Diastolic Blood Pressure
D99
76.8 mmHg
Standard Deviation 6.91
77.9 mmHg
Standard Deviation 6.83

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,D2,D5,D15,D29,D57,D71,D99

Population: All 100 (100%) subjects were included in the analysis set

Urine specific gravity as assessed by laboratory tests up to 99 days post-treatment

Outcome measures

Outcome measures
Measure
IBI305
n=50 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Urinalysis
Baseline
1.017 Urine specific gravity
Standard Deviation 0.006
1.017 Urine specific gravity
Standard Deviation 0.006
Urinalysis
D2
1.017 Urine specific gravity
Standard Deviation 0.006
1.017 Urine specific gravity
Standard Deviation 0.005
Urinalysis
D5
1.017 Urine specific gravity
Standard Deviation 0.005
1.018 Urine specific gravity
Standard Deviation 0.005
Urinalysis
D15
1.016 Urine specific gravity
Standard Deviation 0.006
1.017 Urine specific gravity
Standard Deviation 0.006
Urinalysis
D29
1.017 Urine specific gravity
Standard Deviation 0.005
1.017 Urine specific gravity
Standard Deviation 0.005
Urinalysis
D57
1.016 Urine specific gravity
Standard Deviation 0.005
1.018 Urine specific gravity
Standard Deviation 0.006
Urinalysis
D71
1.017 Urine specific gravity
Standard Deviation 0.004
1.016 Urine specific gravity
Standard Deviation 0.005
Urinalysis
D99
1.017 Urine specific gravity
Standard Deviation 0.006
1.019 Urine specific gravity
Standard Deviation 0.006

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,D2,D5,D15,D29,D57,D71,D99

Population: All 100 (100%) subjects were included in the safety analysis set (SS)

Hemoglobin as assessed by laboratory tests up to 99 days post-treatment.

Outcome measures

Outcome measures
Measure
IBI305
n=50 Participants
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 Participants
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Hemoglobin
Baseline
161.0 Hemoglobin (g/L)
Standard Deviation 9.42
163.5 Hemoglobin (g/L)
Standard Deviation 9.52
Hemoglobin
D2
158.8 Hemoglobin (g/L)
Standard Deviation 11.53
160.4 Hemoglobin (g/L)
Standard Deviation 9.21
Hemoglobin
D5
165.4 Hemoglobin (g/L)
Standard Deviation 10.93
167.7 Hemoglobin (g/L)
Standard Deviation 10.02
Hemoglobin
D15
160.9 Hemoglobin (g/L)
Standard Deviation 10.67
164.5 Hemoglobin (g/L)
Standard Deviation 9.21
Hemoglobin
D29
161.1 Hemoglobin (g/L)
Standard Deviation 10.01
164.5 Hemoglobin (g/L)
Standard Deviation 11.03
Hemoglobin
D57
160.4 Hemoglobin (g/L)
Standard Deviation 12.45
165.5 Hemoglobin (g/L)
Standard Deviation 10.42
Hemoglobin
D71
159.8 Hemoglobin (g/L)
Standard Deviation 12.19
163.9 Hemoglobin (g/L)
Standard Deviation 9.12
Hemoglobin
D99
154.6 Hemoglobin (g/L)
Standard Deviation 11.01
159.9 Hemoglobin (g/L)
Standard Deviation 10.22

Adverse Events

IBI305

Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths

Bevacizumab

Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
IBI305
n=50 participants at risk
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 participants at risk
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Musculoskeletal and connective tissue disorders
hand injury
2.0%
1/50 • Number of events 1 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
0.00%
0/50 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.

Other adverse events

Other adverse events
Measure
IBI305
n=50 participants at risk
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
Bevacizumab
n=50 participants at risk
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
Metabolism and nutrition disorders
Hypertriglyceridemia
22.0%
11/50 • Number of events 25 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
26.0%
13/50 • Number of events 24 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
ALT increased
20.0%
10/50 • Number of events 12 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
24.0%
12/50 • Number of events 17 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Metabolism and nutrition disorders
Hyperglycemia
14.0%
7/50 • Number of events 8 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
18.0%
9/50 • Number of events 11 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
AST increased
12.0%
6/50 • Number of events 8 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
20.0%
10/50 • Number of events 12 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
White blood cell count increased
12.0%
6/50 • Number of events 9 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
16.0%
8/50 • Number of events 9 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
Neutrophil count increased
10.0%
5/50 • Number of events 7 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
16.0%
8/50 • Number of events 9 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Cardiac disorders
Sinus bradycardia
8.0%
4/50 • Number of events 6 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
6.0%
3/50 • Number of events 4 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
White blood cell count decreased
8.0%
4/50 • Number of events 7 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
4.0%
2/50 • Number of events 5 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
Red blood cells urine positive
8.0%
4/50 • Number of events 4 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
2.0%
1/50 • Number of events 1 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
Neutrophil count decreased
6.0%
3/50 • Number of events 5 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
6.0%
3/50 • Number of events 8 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Nervous system disorders
Headache
6.0%
3/50 • Number of events 4 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
0.00%
0/50 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Psychiatric disorders
Intermediate insomnia
6.0%
3/50 • Number of events 3 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
0.00%
0/50 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
Bilirubin increased
4.0%
2/50 • Number of events 3 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
12.0%
6/50 • Number of events 8 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
Investigations
White blood cells urine positive
4.0%
2/50 • Number of events 3 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.
10.0%
5/50 • Number of events 7 • from participants are enrolled to 99 days after infusion
The analysis population consisted of all participants.

Additional Information

Yi Bo

Innovent Biologics (Suzhou) Co., Ltd. (seal)

Phone: +86 13382419112

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place