A Study Comparing SIBP-04 and Bevacizumab in Healthy Male Subjects

NCT04135898 | Completed Phase 1

• 1 other identifier: SIBP-04-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, double-blind, positive drug parallel controlled clinical trial in China. In the trial, it is planned to enroll 88 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.

Conditions

Healthy Male

Outcome Measures

Primary Outcomes (1)

• AUC0-t

  Area under the concentration time curve of the analyte in serum over the time interval from 0 to the last measurable concentration at time "t"

  From 0 to day 71

Secondary Outcomes (8)

• Cmax

  From 0 to day 71

• AUCinf

  From 0 to day 71

• Tmax

  From 0 to day 71

• t1/2

  From 0 to day 71

• λz

  From 0 to day 71

Study Arms (2)

SIBP-04

EXPERIMENTAL

Drug: SIBP-04

Bevacizumab

ACTIVE COMPARATOR

Drug: Bevacizumab

Interventions

SIBP-04 DRUG

3mg/kg, infusion in 90 minutes

SIBP-04

Bevacizumab DRUG

3mg/kg, infusion in 90 minutes

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who are able and willing to give written informed consent.
• years old, male.
• Body mass index (BMI): 18-26 kg/m2 (including 18 kg/m2 and 26 kg/m2), and weighing between 50-80 kg (including 50 kg and 80 kg).
• Subjects determined healthy by Vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, fecal occult blood, etc.), 12-lead electrocardiogram, chest X-ray, abdominal ultrasound, urinary ultrasound, without any clinically significant abnormality judged by the investigator.
• Subjects who are willing to comply with the contraception restrictions from signing of the informed consent form until 6 months after the infusion of the test drug.
• Subjects who can participate in the visit on time and complete the visit.

You may not qualify if:

• Subjects with the following diseases, including but not limited to: nervous system, cardiovascular system, blood and lymphatic system, immune system, digestive system, respiratory system, metabolism and bone diseases.
• History of digestive tract perforation or digestive tract disease.
• Subjects who are allergic to Avastin® and its ingredients.
• History of autoimmune diseases or allergic diseases.
• History of clinically significant proteinuria (urine routine examination, urinary protein 2+and above) or proteinuria judged by the investigator.
• Any inherited predisposition to bleeding or to thrombosis or history of non traumatic hemorrhage (i.e., requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count \< 125000/µL) or an international normalized ratio (INR) higher than 1.5.
• Subjects who did strenuous exercise 96 hours before the test, or participate in intense physical activity within 30 days after the scheduled dose, including physical contact or impact sports;
• Subject with a family history of cancer or a malignant tumor within the past 5 years.
• Abnormal ECG with clinical significance judged by the Investigator.
• Subjects with relevant family history of hypertension or abnormal blood pressure at screening or admission to the study center (Day 1): (Systolic blood pressure ≤ 90mmHg or ≥ 140mmHg, or / and diastolic blood pressure ≤ 60mmHg or ≥ 90mmHg), heart rate ≤ 50bpm or ≥ 100bpm.
• Subjects who have acute or chronic infectious diseases and have clinical significance during the screening and admission studies, or hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), syphilis test positive during the screening.
• History of prior exposure to bevacizumab or any anti VEGF monoclonal antibodies or proteins.
• Live virus vaccination within 3 months prior to study drug administration， or prior exposure to any other investigational monoclonal antibody within 9 months.
• Intake of prescribed or over the counter drugs within 5 half-life of the drug or 2 weeks prior to the use of the test drug, or intake of herbal drugs or dietary supplements within 28 days prior to randomization.
• Use of any investigational drug in any clinical study within the 3 months prior to Sign informed consent.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

the First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shanghai Institute Of Biological Products Co., Ltd

  SINOPHARM

  STUDY DIRECTOR

• The First Affiliated Hospital

  Bengbu Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: October 23, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (1)