HealthyPhase 1NCT03083990

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

A Phase 1 study testing IBI305(Bevacizumab Biosimilar) and Avastin(Bevacizumab) in people with Healthy, run by Innovent Biologics (Suzhou) Co. Ltd. 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

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Trial summary

To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers . Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: IBI305(Bevacizumab Biosimilar) and Avastin(Bevacizumab)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: 9 Mar 2017to 17 Aug 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

China1 site

Jilin University First Hospital
Changchun, Jilin

Other trials in China

About this study

Official title: 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

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

Conditions: Healthy
Being tested: IBI305(Bevacizumab Biosimilar), Avastin(Bevacizumab)

What participants receive

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

IBI305(Bevacizumab Biosimilar)Biological
3mg/kg, infusion in 90minutes
Avastin(Bevacizumab)Drug
Also called avastin
3mg/kg, infusion in 90minutes

Study groups in NCT03083990
Study group	Role	What they receive
Group A	Experimental	IBI 305 ,3mg/kg, infusion in 90 minutes Receives: Biological: IBI305(Bevacizumab Biosimilar)
Group B	Active comparator	Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes Receives: Drug: Avastin(Bevacizumab)

What is being measured

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

AUC0 - t
the area under the blood drug concentration time curve form 0 to t (AUC0 - t)
Measured: 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
AUC0 - ∞
the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞)
Measured: 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

Secondary outcomes (4)

Cmax
Maximum serum concentration
Measured: 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
t1/2
elimination half life
Measured: 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
Clearance Rate
apparent clearance
Measured: 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
Apparent Volume of Distribution
apparent volume of distribution(V）
Measured: 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

Timeline

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

9 Mar 201717 Aug 2017

First posted20 Mar 2017
Study start9 Mar 2017
Primary completion17 Aug 2017
Study completion17 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03083990
Sponsor's protocol ID: CIBI305A201
Status last verified: Nov 2020
First submitted: 12 Nov 2016
Last updated: 27 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03083990
Acronym / sponsor ID: CIBI305A201
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 9 Mar 2017 (actual)
Primary completion: 17 Aug 2017 (actual)
Study completion: 17 Aug 2017 (actual)
First posted: 20 Mar 2017 (actual)
Results: Posted 4 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Biological: IBI305(Bevacizumab Biosimilar)IBI 305 ,3mg/kg, infusion in 90 minutes
Group B	Active comparator	Drug: Avastin(Bevacizumab)Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

To be eligible for the study, patients should fulfill all the following criteria:

Key exclusion criteria (19 listed)

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IBI305(Bevacizumab Biosimilar)3mg/kg, infusion in 90minutes	Biological	Group A
Avastin(Bevacizumab)Also: avastin3mg/kg, infusion in 90minutes	Drug	Group B

Primary outcome

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

4 secondary outcomes

Cmax
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
t1/2
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
Clearance Rate
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
Apparent Volume of Distribution
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

Results and safety

Results posted to the registry on 4 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IBI305	50	49
Bevacizumab	50	50

Primary outcome: 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. Geometric mean (Standard Deviation). Unit: h*ug/mL

Measure	IBI305 n = 48	Bevacizumab n = 50
Value	19704.2 (18.8)	20736.9 (19.1)

IBI305 vs Bevacizumab: Odds Ratio (OR): 0.9502 (90% CI 0.8921 to 1.0120), p >0.05, ANOVA

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

Primary outcome: AUC0 - ∞

Measure	IBI305 n = 48	Bevacizumab n = 50
Value	20180.2 (18.6)	21281.4 (19.8)

IBI305 vs Bevacizumab: Odds Ratio (OR): 0.9483 (90% CI 0.8896 to 1.0108), p >0.05, ANOVA

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

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: from participants are enrolled to 99 days after infusion. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IBI305	1 of 50 (2%)	40 of 50 (80%)	0 of 50
Bevacizumab	0 of 50 (0%)	40 of 50 (80%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

yanhua Ding, Doctor principal investigator

Jilin University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI305(Bevacizumab Biosimilar) and Avastin(Bevacizumab) in people with Healthy, run by Innovent Biologics (Suzhou) Co. Ltd. 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 19 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 27 Nov 2020. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: 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). The study lists 2 primary outcomes in all. 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 NCT03083990.

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 27 Nov 2020.