Phase 1
Completed N=100
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
| Outcome | Result | p-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
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.