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

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ClinicalTrials.gov Identifier: NCT03083990
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : November 4, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Healthy
Interventions Biological: IBI305(Bevacizumab Biosimilar)
Drug: Avastin(Bevacizumab)
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Period Title: Overall Study
Started 50 50
Completed 49 50
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title IBI305 Bevacizumab Total
Hide Arm/Group Description

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Total of all reporting groups
Overall Number of Baseline Participants 48 50 98
Hide Baseline Analysis Population Description
The baseline demographics of the subjects were analyzed based on the Pharmacokinetics analysis set.A total of 98 (98.0%) subjects were included , and 2 (4%) subjects in the IBI305 arm were excluded in the due to positive anti-drug antibody at baseline.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean (SD) Number Analyzed 48 participants 50 participants 98 participants
36.5  (8.92) 34.0  (8.87) 35.2  (8.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 50 participants 98 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
48
 100.0%
50
 100.0%
98
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 50 participants 98 participants
Han
43
  89.6%
45
  90.0%
88
  89.8%
Others
5
  10.4%
5
  10.0%
10
  10.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 48 participants 50 participants 98 participants
48
 100.0%
50
 100.0%
98
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 48 participants 50 participants 98 participants
169.7  (5.69) 169.0  (5.12) 169.3  (5.39)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 48 participants 50 participants 98 participants
67.32  (7.763) 68.42  (6.629) 67.88  (7.191)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 48 participants 50 participants 98 participants
23.414  (2.739) 23.962  (2.040) 23.694  (2.412)
1.Primary Outcome
Title AUC0 - t
Hide Description the area under the blood drug concentration time curve form 0 to t (AUC0 - t)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 48 50
Geometric Mean (Standard Deviation)
Unit of Measure: h*ug/mL
19704.2  (18.8) 20736.9  (19.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IBI305, Bevacizumab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9502
Confidence Interval (2-Sided) 90%
0.8921 to 1.0120
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUC0 - ∞
Hide Description the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 48 50
Geometric Mean (Standard Deviation)
Unit of Measure: h*ug/mL
20180.2  (18.6) 21281.4  (19.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IBI305, Bevacizumab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9483
Confidence Interval (2-Sided) 90%
0.8896 to 1.0108
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Cmax
Hide Description Maximum serum concentration
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 48 50
Geometric Mean (Standard Deviation)
Unit of Measure: ug/mL
65.3  (21.0) 67.0  (18.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IBI305, Bevacizumab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9749
Confidence Interval (2-Sided) 90%
0.9123 to 1.0418
Estimation Comments [Not Specified]
4.Secondary Outcome
Title t1/2
Hide Description elimination half life
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 48 50
Mean (Standard Deviation)
Unit of Measure: hour
340.2  (51.1) 356.5  (69.6)
5.Secondary Outcome
Title Clearance Rate
Hide Description apparent clearance
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 48 50
Mean (Standard Deviation)
Unit of Measure: ml/h/kg
0.151  (0.0296) 0.144  (0.0281)
6.Secondary Outcome
Title Apparent Volume of Distribution
Hide Description apparent volume of distribution(V)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects in the IBI305 arm were not included in the PKAS(PK analysis set) because of positive ADA at baseline
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 48 50
Mean (Standard Deviation)
Unit of Measure: ml/kg
73.8  (15.9) 72.3  (12.8)
7.Other Pre-specified Outcome
Title Number of Participants Positive for Nab(Neutralizing Antibody)
Hide Description The analysis of NAb was done by Covance Pharmaceutical R&D (Shanghai) Co., Ltd. using methodologically validated ECL immunoassay.
Time Frame 99 days after administration
Hide Outcome Measure Data
Hide Analysis Population Description
All 100 (100%) subjects were included in the NAb-AS (Neutralizing anti-body analysis set)
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
Baseline 2 0
D15 4 0
D43 2 0
D71 2 0
D99 1 0
8.Other Pre-specified Outcome
Title Number of Participants Positive for Anti-drug Antibodies
Hide Description The analysis of ADA was done by Wuxi AppTec (Shanghai) Co., Ltd. using methodologically validated electrochemiluminescence (ECL) immunoassay.
Time Frame 99 days after administration
Hide Outcome Measure Data
Hide Analysis Population Description
All 100 (100%) subjects were included in the ADA-AS(Anti-drug Antibody Analysis set)
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
Baseline 2 0
D15 4 0
D43 2 0
D71 2 0
D99 1 0
9.Other Pre-specified Outcome
Title Systolic Blood Pressure
Hide Description Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All 100 (100%) subjects were included in the safety analysis set. Blood pressure of certain timepoint was not collected because of serve adverse event.
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline Number Analyzed 50 participants 50 participants
119.6  (8.73) 121.4  (8.02)
D1, immediately after the end of infusion Number Analyzed 50 participants 50 participants
113.3  (10.23) 114.5  (8.7)
D1, 4 hrs after the start of infusion Number Analyzed 50 participants 50 participants
118.0  (9.60) 119.6  (7.87)
D1, 8 hrs after the start of infusion Number Analyzed 50 participants 50 participants
120.4  (9.48) 120.3  (8.30)
D1, 12 hrs after the start of infusion Number Analyzed 50 participants 50 participants
119.8  (8.67) 123.4  (9.63)
D2 Number Analyzed 50 participants 50 participants
119.8  (9.72) 121.9  (8.81)
D3 Number Analyzed 50 participants 50 participants
120.2  (8.37) 123.2  (9.52)
D5 Number Analyzed 50 participants 50 participants
120.7  (7.97) 121.4  (8.34)
D8 Number Analyzed 50 participants 50 participants
118.4  (7.69) 122.6  (9.22)
D15 Number Analyzed 50 participants 50 participants
118.6  (9.70) 118.5  (10.19)
D22 Number Analyzed 50 participants 50 participants
121.8  (8.73) 122.5  (8.88)
D29 Number Analyzed 50 participants 50 participants
121.6  (9.20) 123.1  (8.91)
D43 Number Analyzed 50 participants 50 participants
119.7  (9.12) 121.3  (9.03)
D57 Number Analyzed 50 participants 50 participants
118.4  (10.30) 122.1  (8.12)
D64 Number Analyzed 49 participants 50 participants
119.4  (8.78) 120.2  (10.00)
D71 Number Analyzed 49 participants 50 participants
118.3  (10.01) 119.8  (10.10)
D85 Number Analyzed 49 participants 50 participants
115.8  (9.04) 120.6  (9.59)
D99 Number Analyzed 49 participants 50 participants
118.2  (7.61) 118.2  (10.66)
10.Other Pre-specified Outcome
Title Diastolic Blood Pressure
Hide Description Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All 100 (100%) subjects were included in the safety analysis set. Blood pressure of certain timepoint was not collected because of serve adverse event.
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline Number Analyzed 50 participants 50 participants
79.2  (8.02) 81.4  (5.94)
D1, immediately after the end of infusion Number Analyzed 50 participants 50 participants
71.8  (7.82) 73.7  (6.64)
D1, 4 hrs after the start of infusion Number Analyzed 50 participants 50 participants
75.5  (6.68) 77.4  (7.13)
D1, 8 hrs after the start of infusion Number Analyzed 50 participants 50 participants
77.8  (5.94) 79.3  (6.95)
D1, 12 hrs after the start of infusion Number Analyzed 50 participants 50 participants
77.0  (6.96) 81.3  (7.37)
D2 Number Analyzed 50 participants 50 participants
79.8  (6.57) 81.6  (6.46)
D3 Number Analyzed 50 participants 50 participants
80.5  (6.45) 82.8  (6.17)
D5 Number Analyzed 50 participants 50 participants
80.4  (8.30) 82.1  (4.71)
D8 Number Analyzed 50 participants 49 participants
78.2  (6.23) 81.4  (6.62)
D15 Number Analyzed 50 participants 50 participants
78.2  (7.67) 79.2  (6.50)
D22 Number Analyzed 50 participants 50 participants
80.5  (6.04) 82.3  (7.47)
D29 Number Analyzed 50 participants 50 participants
79.6  (6.43) 81.6  (7.02)
D43 Number Analyzed 50 participants 50 participants
79.5  (7.34) 80.0  (6.96)
D57 Number Analyzed 50 participants 50 participants
78.6  (7.87) 82.2  (6.18)
D64 Number Analyzed 49 participants 50 participants
78.7  (7.33) 80.5  (6.18)
D71 Number Analyzed 49 participants 50 participants
77.1  (8.01) 80.2  (6.32)
D85 Number Analyzed 49 participants 50 participants
79.2  (6.96) 80.0  (6.42)
D99 Number Analyzed 49 participants 50 participants
76.8  (6.91) 77.9  (6.83)
11.Other Pre-specified Outcome
Title Urinalysis
Hide Description Urine specific gravity as assessed by laboratory tests up to 99 days post-treatment
Time Frame Baseline,D2,D5,D15,D29,D57,D71,D99
Hide Outcome Measure Data
Hide Analysis Population Description
All 100 (100%) subjects were included in the analysis set
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: Urine specific gravity
Baseline 1.017  (0.006) 1.017  (0.006)
D2 1.017  (0.006) 1.017  (0.005)
D5 1.017  (0.005) 1.018  (0.005)
D15 1.016  (0.006) 1.017  (0.006)
D29 1.017  (0.005) 1.017  (0.005)
D57 1.016  (0.005) 1.018  (0.006)
D71 1.017  (0.004) 1.016  (0.005)
D99 1.017  (0.006) 1.019  (0.006)
12.Other Pre-specified Outcome
Title Hemoglobin
Hide Description Hemoglobin as assessed by laboratory tests up to 99 days post-treatment.
Time Frame Baseline,D2,D5,D15,D29,D57,D71,D99
Hide Outcome Measure Data
Hide Analysis Population Description
All 100 (100%) subjects were included in the safety analysis set (SS)
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: Hemoglobin (g/L)
Baseline 161.0  (9.42) 163.5  (9.52)
D2 158.8  (11.53) 160.4  (9.21)
D5 165.4  (10.93) 167.7  (10.02)
D15 160.9  (10.67) 164.5  (9.21)
D29 161.1  (10.01) 164.5  (11.03)
D57 160.4  (12.45) 165.5  (10.42)
D71 159.8  (12.19) 163.9  (9.12)
D99 154.6  (11.01) 159.9  (10.22)
Time Frame from participants are enrolled to 99 days after infusion
Adverse Event Reporting Description The analysis population consisted of all participants.
 
Arm/Group Title IBI305 Bevacizumab
Hide Arm/Group Description

IBI 305 ,3mg/kg, infusion in 90 minutes

IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes

All-Cause Mortality
IBI305 Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
IBI305 Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/50 (2.00%)      0/50 (0.00%)    
Musculoskeletal and connective tissue disorders     
hand injury  1  1/50 (2.00%)  1 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA(19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IBI305 Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/50 (80.00%)      40/50 (80.00%)    
Cardiac disorders     
Sinus bradycardia  1  4/50 (8.00%)  6 3/50 (6.00%)  4
Investigations     
ALT increased  1  10/50 (20.00%)  12 12/50 (24.00%)  17
AST increased  1  6/50 (12.00%)  8 10/50 (20.00%)  12
White blood cell count increased  1  6/50 (12.00%)  9 8/50 (16.00%)  9
Neutrophil count increased  1  5/50 (10.00%)  7 8/50 (16.00%)  9
White blood cell count decreased  1  4/50 (8.00%)  7 2/50 (4.00%)  5
Red blood cells urine positive  1  4/50 (8.00%)  4 1/50 (2.00%)  1
Neutrophil count decreased  1  3/50 (6.00%)  5 3/50 (6.00%)  8
Bilirubin increased  1  2/50 (4.00%)  3 6/50 (12.00%)  8
White blood cells urine positive  1  2/50 (4.00%)  3 5/50 (10.00%)  7
Metabolism and nutrition disorders     
Hypertriglyceridemia  1  11/50 (22.00%)  25 13/50 (26.00%)  24
Hyperglycemia  1  7/50 (14.00%)  8 9/50 (18.00%)  11
Nervous system disorders     
Headache  1  3/50 (6.00%)  4 0/50 (0.00%)  0
Psychiatric disorders     
Intermediate insomnia  1  3/50 (6.00%)  3 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA(19.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yi Bo
Organization: Innovent Biologics (Suzhou) Co., Ltd. (seal)
Phone: +86 13382419112
EMail: jessica.yi@innoventbio.com
Layout table for additonal information
Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03083990    
Other Study ID Numbers: CIBI305A201
First Submitted: November 12, 2016
First Posted: March 20, 2017
Results First Submitted: July 6, 2020
Results First Posted: November 4, 2020
Last Update Posted: November 27, 2020