AzTrials
AzTrials

Healthy MalePhase 1NCT04135898

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

A Phase 1 study testing SIBP-04 and Bevacizumab in people with Healthy Male, run by Shanghai Institute Of Biological Products at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male
What is being tested?
SIBP-04 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
23 Oct 2019to 16 Mar 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who are able and willing to give written informed consent.
  • 18-45 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.
  • Blood loss or blood donation (including blood components donation) ≥ 400 mL or blood transfusion within 3 months before study drug administration.
  • Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected major surgery during the study period or 2 months after the end of the study.
  • Plan to receive oral or dental surgery during the study period.
  • History of alcohol abuse or a positive alcohol breath test before study drug administration.
  • History of drug abuse, or have positive drug screening results.
  • Subjects who have more than 5 cigarettes per day within 3 months before enrollment.
  • Others that are not in compliance with the enrollment judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

Other trials in China

About this study

Official title: A Randomized, Double-blind, Phase I Study Comparing the Pharmacokinetic and Safety of SIBP-04 and Bevacizumab in Healthy Male Subjects

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
Being tested
SIBP-04, Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIBP-04Drug

    3mg/kg, infusion in 90 minutes

  • BevacizumabDrug

    3mg/kg, infusion in 90 minutes

Study groups in NCT04135898
Study groupRoleWhat they receive
SIBP-04ExperimentalNot described
Receives: Drug: SIBP-04
BevacizumabActive comparatorNot described
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: From 0 to day 71

Secondary outcomes (8)

  1. Cmax

    Maximum measured concentration of the analyte in serum

    Measured: From 0 to day 71

  2. AUCinf

    Area under the concentration time curve of the analyte in serum over the time interval from 0 to extrapolated to infinite time

    Measured: From 0 to day 71

  3. Tmax

    Time from dosing to maximum measured concentration

    Measured: From 0 to day 71

  4. t1/2

    Terminal half life of the analyte in serum

    Measured: From 0 to day 71

  5. λz

    Terminal elimination rate constant

    Measured: From 0 to day 71

  6. CL

    Total clearance of the analyte in serum following IV infusion

    Measured: From 0 to day 71

  7. Vd

    Volume of distribution during the terminal phase λz following an intravascular dose

    Measured: From 0 to day 71

  8. Immunogenicity

    Incidence of anti drug antibodies (ADAs) and neutralizing anti drug antibodies（NAb）

    Measured: From 0 to day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start23 Oct 2019
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135898
Sponsor's protocol ID
SIBP-04-01
Status last verified
Dec 2023
First submitted
21 Oct 2019
Last updated
29 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIBP-04 and Bevacizumab in people with Healthy Male, run by Shanghai Institute Of Biological Products at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-t (time frame: From 0 to day 71). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04135898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in