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Phase 1 Completed N=100 Randomized Double-blind Treatment

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

Healthy
Source: ClinicalTrials.gov NCT03083990 ↗
Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Nov 2020
Primary outcomePrimary: AUC0 - t — 19704.2; 20736.9 h*ug/mL — p=>0.05

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
AUC0 - t
19704.2; 20736.9 >0.05
PRIMARY
AUC0 - ∞
20180.2; 21281.4 >0.05
SECONDARY
Cmax
65.3; 67.0 >0.05
SECONDARY
t1/2
340.2; 356.5
SECONDARY
Clearance Rate
0.151; 0.144
SECONDARY
Apparent Volume of Distribution
73.8; 72.3

Eligibility Criteria

Inclusion Criteria

  • To be eligible for the study, patients should fulfill all the following criteria:
  • 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.
  • Age ≥18 and ≤ 50, healthy male subjects
  • Weigh ≥ 50 kg and ≤ 100 kg, BMI≥ 19 and ≤ 28 kg/m2
  • All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator.
  • 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 exclusion criteria are fulfilled:
  • Medical history of high blood pressure or abnormal blood pressure at screening/baseline(Double confirmed systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg within one day)
  • Proteinuria with clinical significance judged by the investigator (routine urine examination, urine protein 2 + and above) or a history of proteinuria.
  • Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.
  • Any biological products or a live virus vaccine treatment within 3 months , or any monoclonal antibodies within 12 months before the first dose of study drug.
  • History or evidence of inherited bleeding diathesis or coagulopathy or thrombus.
  • History of digestive tract perforation or digestive tract fistula.
  • Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after last dose of the study drug.
  • Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.
  • Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis
  • Known hypersensitivity to Bevacizumab or any excipients
  • Known allergic disease or allergic constitution
  • History of blood donation within 3 months before the first dose of study drug
  • Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening
  • History of alcoholism or drug abuse within 12 months prior to screening; Subjects cannot temperance within 72 hours before study drug infusion and during the whole study
  • History of mental illness
  • Anticipated of partner pregnancy during the study.
  • Incompliance to the clinical study protocol during the study.
  • Other conditions that the investigator thinks unsuitable in this study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03083990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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