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

Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03083990
Enrollment
100
Registered
2017-03-20
Start date
2017-03-09
Completion date
2017-08-17
Last updated
2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .

Interventions

BIOLOGICALIBI305(Bevacizumab Biosimilar)

3mg/kg, infusion in 90minutes

DRUGAvastin(Bevacizumab)

3mg/kg, infusion in 90minutes

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* To be eligible for the study, patients should fulfill all the following criteria: 1. Fully understand the study purpose, and understand the pharmacological effects and potential adverse reactions of the drug, voluntarily signed written informed consent according to the declaration of Helsinki. 2. Age ≥18 and ≤ 50, healthy male subjects 3. Weigh ≥ 50 kg and ≤ 100 kg， BMI≥ 19 and ≤ 28 kg/m2 4. All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator. 5. The subjects must agree to use effective contraceptive measures during the study treatment and for 6 months after receiving last does of study drug (e.g. abstinence, sterilization surgery, oral contraceptives, contraception by progesterone injection or subcutaneous)

Exclusion criteria

* Patients should not enter the study if any of the following

Design outcomes

Primary

MeasureTime frameDescription
AUC0 - t60 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 daysthe area under the blood drug concentration time curve form 0 to t (AUC0 - t)
AUC0 - ∞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 daysthe area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞)

Secondary

MeasureTime frameDescription
Cmax60 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 daysMaximum serum concentration
t1/260 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 dayselimination half life
Clearance Rate60 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 daysapparent clearance
Apparent Volume of Distribution60 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 daysapparent volume of distribution(V）

Other

MeasureTime frameDescription
Number of Participants Positive for Nab（Neutralizing Antibody）99 days after administrationThe analysis of NAb was done by Covance Pharmaceutical R&D (Shanghai) Co., Ltd. using methodologically validated ECL immunoassay.
Number of Participants Positive for Anti-drug Antibodies99 days after administrationThe analysis of ADA was done by Wuxi AppTec (Shanghai) Co., Ltd. using methodologically validated electrochemiluminescence (ECL) immunoassay.
Systolic Blood Pressure0, 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, D99Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.
Diastolic Blood Pressure0, 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, D99Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.
UrinalysisBaseline,D2,D5,D15,D29,D57,D71,D99Urine specific gravity as assessed by laboratory tests up to 99 days post-treatment
HemoglobinBaseline,D2,D5,D15,D29,D57,D71,D99Hemoglobin as assessed by laboratory tests up to 99 days post-treatment.

Countries

China

Participant flow

Participants by arm

ArmCount
IBI305
IBI 305 ,3mg/kg, infusion in 90 minutes IBI305(Bevacizumab Biosimilar): 3mg/kg, infusion in 90minutes
48
Bevacizumab
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Avastin(Bevacizumab): 3mg/kg, infusion in 90minutes
50
Total98

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10

Baseline characteristics

CharacteristicIBI305BevacizumabTotal
Age, Continuous
Mean (SD)
36.5 years
STANDARD_DEVIATION 8.92
34.0 years
STANDARD_DEVIATION 8.87
35.2 years
STANDARD_DEVIATION 8.94
Body mass index23.414 kg/m2
STANDARD_DEVIATION 2.739
23.962 kg/m2
STANDARD_DEVIATION 2.04
23.694 kg/m2
STANDARD_DEVIATION 2.412
Height169.7 centimeter
STANDARD_DEVIATION 5.69
169.0 centimeter
STANDARD_DEVIATION 5.12
169.3 centimeter
STANDARD_DEVIATION 5.39
Race/Ethnicity, Customized
Han
43 Participants45 Participants88 Participants
Race/Ethnicity, Customized
Others
5 Participants5 Participants10 Participants
Region of Enrollment
China
48 Participants50 Participants98 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
48 Participants50 Participants98 Participants
Weight67.32 kilogram
STANDARD_DEVIATION 7.763
68.42 kilogram
STANDARD_DEVIATION 6.629
67.88 kilogram
STANDARD_DEVIATION 7.191

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
40 / 5040 / 50
serious
Total, serious adverse events
1 / 500 / 50

Outcome results

Primary

AUC0 - ∞

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

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

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
IBI305AUC0 - ∞20180.2 h*ug/mLStandard Deviation 18.6
BevacizumabAUC0 - ∞21281.4 h*ug/mLStandard Deviation 19.8
p-value: >0.0590% CI: [0.8896, 1.0108]ANOVA
Primary

AUC0 - t

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

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

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
IBI305AUC0 - t19704.2 h*ug/mLStandard Deviation 18.8
BevacizumabAUC0 - t20736.9 h*ug/mLStandard Deviation 19.1
p-value: >0.0590% CI: [0.8921, 1.012]ANOVA
Secondary

Apparent Volume of Distribution

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

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

ArmMeasureValue (MEAN)Dispersion
IBI305Apparent Volume of Distribution73.8 ml/kgStandard Deviation 15.9
BevacizumabApparent Volume of Distribution72.3 ml/kgStandard Deviation 12.8
Secondary

Clearance Rate

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

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

ArmMeasureValue (MEAN)Dispersion
IBI305Clearance Rate0.151 ml/h/kgStandard Deviation 0.0296
BevacizumabClearance Rate0.144 ml/h/kgStandard Deviation 0.0281
Secondary

Cmax

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

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

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
IBI305Cmax65.3 ug/mLStandard Deviation 21
BevacizumabCmax67.0 ug/mLStandard Deviation 18.9
p-value: >0.0590% CI: [0.9123, 1.0418]ANOVA
Secondary

t1/2

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

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

ArmMeasureValue (MEAN)Dispersion
IBI305t1/2340.2 hourStandard Deviation 51.1
Bevacizumabt1/2356.5 hourStandard Deviation 69.6
Other Pre-specified

Diastolic Blood Pressure

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

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.

ArmMeasureGroupValue (MEAN)Dispersion
IBI305Diastolic Blood PressureD1, 8 hrs after the start of infusion77.8 mmHgStandard Deviation 5.94
IBI305Diastolic Blood PressureD1578.2 mmHgStandard Deviation 7.67
IBI305Diastolic Blood PressureD1, immediately after the end of infusion71.8 mmHgStandard Deviation 7.82
IBI305Diastolic Blood PressureD2280.5 mmHgStandard Deviation 6.04
IBI305Diastolic Blood PressureD1, 12 hrs after the start of infusion77.0 mmHgStandard Deviation 6.96
IBI305Diastolic Blood PressureD2979.6 mmHgStandard Deviation 6.43
IBI305Diastolic Blood PressureD580.4 mmHgStandard Deviation 8.3
IBI305Diastolic Blood PressureD4379.5 mmHgStandard Deviation 7.34
IBI305Diastolic Blood PressureD279.8 mmHgStandard Deviation 6.57
IBI305Diastolic Blood PressureD5778.6 mmHgStandard Deviation 7.87
IBI305Diastolic Blood PressureD1, 4 hrs after the start of infusion75.5 mmHgStandard Deviation 6.68
IBI305Diastolic Blood PressureD6478.7 mmHgStandard Deviation 7.33
IBI305Diastolic Blood PressureD380.5 mmHgStandard Deviation 6.45
IBI305Diastolic Blood PressureD7177.1 mmHgStandard Deviation 8.01
IBI305Diastolic Blood PressureD878.2 mmHgStandard Deviation 6.23
IBI305Diastolic Blood PressureD8579.2 mmHgStandard Deviation 6.96
IBI305Diastolic Blood PressureD9976.8 mmHgStandard Deviation 6.91
IBI305Diastolic Blood PressureBaseline79.2 mmHgStandard Deviation 8.02
BevacizumabDiastolic Blood PressureD9977.9 mmHgStandard Deviation 6.83
BevacizumabDiastolic Blood PressureD582.1 mmHgStandard Deviation 4.71
BevacizumabDiastolic Blood PressureD8580.0 mmHgStandard Deviation 6.42
BevacizumabDiastolic Blood PressureBaseline81.4 mmHgStandard Deviation 5.94
BevacizumabDiastolic Blood PressureD1, immediately after the end of infusion73.7 mmHgStandard Deviation 6.64
BevacizumabDiastolic Blood PressureD1, 4 hrs after the start of infusion77.4 mmHgStandard Deviation 7.13
BevacizumabDiastolic Blood PressureD1, 8 hrs after the start of infusion79.3 mmHgStandard Deviation 6.95
BevacizumabDiastolic Blood PressureD1, 12 hrs after the start of infusion81.3 mmHgStandard Deviation 7.37
BevacizumabDiastolic Blood PressureD281.6 mmHgStandard Deviation 6.46
BevacizumabDiastolic Blood PressureD382.8 mmHgStandard Deviation 6.17
BevacizumabDiastolic Blood PressureD881.4 mmHgStandard Deviation 6.62
BevacizumabDiastolic Blood PressureD1579.2 mmHgStandard Deviation 6.5
BevacizumabDiastolic Blood PressureD2282.3 mmHgStandard Deviation 7.47
BevacizumabDiastolic Blood PressureD2981.6 mmHgStandard Deviation 7.02
BevacizumabDiastolic Blood PressureD4380.0 mmHgStandard Deviation 6.96
BevacizumabDiastolic Blood PressureD5782.2 mmHgStandard Deviation 6.18
BevacizumabDiastolic Blood PressureD6480.5 mmHgStandard Deviation 6.18
BevacizumabDiastolic Blood PressureD7180.2 mmHgStandard Deviation 6.32
Other Pre-specified

Hemoglobin

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

Time frame: Baseline,D2,D5,D15,D29,D57,D71,D99

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

ArmMeasureGroupValue (MEAN)Dispersion
IBI305HemoglobinBaseline161.0 Hemoglobin (g/L)Standard Deviation 9.42
IBI305HemoglobinD2158.8 Hemoglobin (g/L)Standard Deviation 11.53
IBI305HemoglobinD5165.4 Hemoglobin (g/L)Standard Deviation 10.93
IBI305HemoglobinD15160.9 Hemoglobin (g/L)Standard Deviation 10.67
IBI305HemoglobinD29161.1 Hemoglobin (g/L)Standard Deviation 10.01
IBI305HemoglobinD57160.4 Hemoglobin (g/L)Standard Deviation 12.45
IBI305HemoglobinD71159.8 Hemoglobin (g/L)Standard Deviation 12.19
IBI305HemoglobinD99154.6 Hemoglobin (g/L)Standard Deviation 11.01
BevacizumabHemoglobinD99159.9 Hemoglobin (g/L)Standard Deviation 10.22
BevacizumabHemoglobinBaseline163.5 Hemoglobin (g/L)Standard Deviation 9.52
BevacizumabHemoglobinD29164.5 Hemoglobin (g/L)Standard Deviation 11.03
BevacizumabHemoglobinD2160.4 Hemoglobin (g/L)Standard Deviation 9.21
BevacizumabHemoglobinD71163.9 Hemoglobin (g/L)Standard Deviation 9.12
BevacizumabHemoglobinD5167.7 Hemoglobin (g/L)Standard Deviation 10.02
BevacizumabHemoglobinD57165.5 Hemoglobin (g/L)Standard Deviation 10.42
BevacizumabHemoglobinD15164.5 Hemoglobin (g/L)Standard Deviation 9.21
Other Pre-specified

Number of Participants Positive for Anti-drug Antibodies

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

Time frame: 99 days after administration

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

ArmMeasureGroupValue (NUMBER)
IBI305Number of Participants Positive for Anti-drug AntibodiesD432 Participants
IBI305Number of Participants Positive for Anti-drug AntibodiesBaseline2 Participants
IBI305Number of Participants Positive for Anti-drug AntibodiesD712 Participants
IBI305Number of Participants Positive for Anti-drug AntibodiesD154 Participants
IBI305Number of Participants Positive for Anti-drug AntibodiesD991 Participants
BevacizumabNumber of Participants Positive for Anti-drug AntibodiesD150 Participants
BevacizumabNumber of Participants Positive for Anti-drug AntibodiesD990 Participants
BevacizumabNumber of Participants Positive for Anti-drug AntibodiesD430 Participants
BevacizumabNumber of Participants Positive for Anti-drug AntibodiesD710 Participants
BevacizumabNumber of Participants Positive for Anti-drug AntibodiesBaseline0 Participants
Other Pre-specified

Number of Participants Positive for Nab（Neutralizing Antibody）

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

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

ArmMeasureGroupValue (NUMBER)
IBI305Number of Participants Positive for Nab（Neutralizing Antibody）D154 Participants
IBI305Number of Participants Positive for Nab（Neutralizing Antibody）D712 Participants
IBI305Number of Participants Positive for Nab（Neutralizing Antibody）D432 Participants
IBI305Number of Participants Positive for Nab（Neutralizing Antibody）D991 Participants
IBI305Number of Participants Positive for Nab（Neutralizing Antibody）Baseline2 Participants
BevacizumabNumber of Participants Positive for Nab（Neutralizing Antibody）D990 Participants
BevacizumabNumber of Participants Positive for Nab（Neutralizing Antibody）Baseline0 Participants
BevacizumabNumber of Participants Positive for Nab（Neutralizing Antibody）D150 Participants
BevacizumabNumber of Participants Positive for Nab（Neutralizing Antibody）D430 Participants
BevacizumabNumber of Participants Positive for Nab（Neutralizing Antibody）D710 Participants
Other Pre-specified

Systolic Blood Pressure

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

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.

ArmMeasureGroupValue (MEAN)Dispersion
IBI305Systolic Blood PressureBaseline119.6 mmHgStandard Deviation 8.73
IBI305Systolic Blood PressureD29121.6 mmHgStandard Deviation 9.2
IBI305Systolic Blood PressureD43119.7 mmHgStandard Deviation 9.12
IBI305Systolic Blood PressureD57118.4 mmHgStandard Deviation 10.3
IBI305Systolic Blood PressureD99118.2 mmHgStandard Deviation 7.61
IBI305Systolic Blood PressureD3120.2 mmHgStandard Deviation 8.37
IBI305Systolic Blood PressureD1, immediately after the end of infusion113.3 mmHgStandard Deviation 10.23
IBI305Systolic Blood PressureD1, 4 hrs after the start of infusion118.0 mmHgStandard Deviation 9.6
IBI305Systolic Blood PressureD1, 8 hrs after the start of infusion120.4 mmHgStandard Deviation 9.48
IBI305Systolic Blood PressureD1, 12 hrs after the start of infusion119.8 mmHgStandard Deviation 8.67
IBI305Systolic Blood PressureD2119.8 mmHgStandard Deviation 9.72
IBI305Systolic Blood PressureD5120.7 mmHgStandard Deviation 7.97
IBI305Systolic Blood PressureD8118.4 mmHgStandard Deviation 7.69
IBI305Systolic Blood PressureD15118.6 mmHgStandard Deviation 9.7
IBI305Systolic Blood PressureD22121.8 mmHgStandard Deviation 8.73
IBI305Systolic Blood PressureD64119.4 mmHgStandard Deviation 8.78
IBI305Systolic Blood PressureD71118.3 mmHgStandard Deviation 10.01
IBI305Systolic Blood PressureD85115.8 mmHgStandard Deviation 9.04
BevacizumabSystolic Blood PressureD15118.5 mmHgStandard Deviation 10.19
BevacizumabSystolic Blood PressureBaseline121.4 mmHgStandard Deviation 8.02
BevacizumabSystolic Blood PressureD1, 12 hrs after the start of infusion123.4 mmHgStandard Deviation 9.63
BevacizumabSystolic Blood PressureD29123.1 mmHgStandard Deviation 8.91
BevacizumabSystolic Blood PressureD85120.6 mmHgStandard Deviation 9.59
BevacizumabSystolic Blood PressureD43121.3 mmHgStandard Deviation 9.03
BevacizumabSystolic Blood PressureD2121.9 mmHgStandard Deviation 8.81
BevacizumabSystolic Blood PressureD57122.1 mmHgStandard Deviation 8.12
BevacizumabSystolic Blood PressureD22122.5 mmHgStandard Deviation 8.88
BevacizumabSystolic Blood PressureD99118.2 mmHgStandard Deviation 10.66
BevacizumabSystolic Blood PressureD5121.4 mmHgStandard Deviation 8.34
BevacizumabSystolic Blood PressureD3123.2 mmHgStandard Deviation 9.52
BevacizumabSystolic Blood PressureD71119.8 mmHgStandard Deviation 10.1
BevacizumabSystolic Blood PressureD1, immediately after the end of infusion114.5 mmHgStandard Deviation 8.7
BevacizumabSystolic Blood PressureD8122.6 mmHgStandard Deviation 9.22
BevacizumabSystolic Blood PressureD1, 4 hrs after the start of infusion119.6 mmHgStandard Deviation 7.87
BevacizumabSystolic Blood PressureD64120.2 mmHgStandard Deviation 10
BevacizumabSystolic Blood PressureD1, 8 hrs after the start of infusion120.3 mmHgStandard Deviation 8.3
Other Pre-specified

Urinalysis

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

Time frame: Baseline,D2,D5,D15,D29,D57,D71,D99

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

ArmMeasureGroupValue (MEAN)Dispersion
IBI305UrinalysisBaseline1.017 Urine specific gravityStandard Deviation 0.006
IBI305UrinalysisD291.017 Urine specific gravityStandard Deviation 0.005
IBI305UrinalysisD51.017 Urine specific gravityStandard Deviation 0.005
IBI305UrinalysisD571.016 Urine specific gravityStandard Deviation 0.005
IBI305UrinalysisD21.017 Urine specific gravityStandard Deviation 0.006
IBI305UrinalysisD711.017 Urine specific gravityStandard Deviation 0.004
IBI305UrinalysisD151.016 Urine specific gravityStandard Deviation 0.006
IBI305UrinalysisD991.017 Urine specific gravityStandard Deviation 0.006
BevacizumabUrinalysisD991.019 Urine specific gravityStandard Deviation 0.006
BevacizumabUrinalysisBaseline1.017 Urine specific gravityStandard Deviation 0.006
BevacizumabUrinalysisD21.017 Urine specific gravityStandard Deviation 0.005
BevacizumabUrinalysisD51.018 Urine specific gravityStandard Deviation 0.005
BevacizumabUrinalysisD151.017 Urine specific gravityStandard Deviation 0.006
BevacizumabUrinalysisD291.017 Urine specific gravityStandard Deviation 0.005
BevacizumabUrinalysisD571.018 Urine specific gravityStandard Deviation 0.006
BevacizumabUrinalysisD711.016 Urine specific gravityStandard Deviation 0.005

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026