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HealthyPhase 1NCT05113511

PK and Safety of SCT510

A Phase 1 study testing SCT510 and Bevacizumab in people with Healthy, run by First Affiliated Hospital of Zhejiang University 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

This is a randomized, double-blind, parallel-controlled phase I clinical study comparing the pharmacokinetics, safety and immunogenicity of SCT510 with bevacizumab (Avastin®) in Chinese healthy males. 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
What is being tested?
SCT510 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
9 May 2018to 26 Jul 2021
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

  • Healthy volunteers who fully understand the purpose, content, benefits and possible adverse reactions of the test and voluntarily sign written informed consent prior to the commencement of any test-related activities.
  • Healthy males, aged 18 to 45 years (including 18 and 45 years).
  • Male subjects weighed 45-100 kg (including 45 and 100 kg), body mass index (BMI) was 19.0-25.0 kg/m2 (including 19.0 and 25.0 kg/m2), where BMI = body weight (kg)/height2 (m2).
  • The subject agrees to use reliable contraceptive methods (such as abstinence, sterilization, birth control pills, injectable contraceptive meprogesterone or subcutaneous implantation) for himself and his partner during the study period and for 6 months after the infusion of study drugs.

Who cannot join

  • History of hypertension or abnormal blood pressure at screening/baseline [SBP >140 mmHg and/or diastolic blood pressure >90 mmHg confirmed by one repeat measurement on the same day];
  • Clinically significant proteinuria examination or history of proteinuria assessed by the investigator;
  • Abnormal physical examination or examination results (e.g., chest X-ray, laboratory examination) are considered clinically significant by the investigator;
  • Have received any antibody or protein drug or small molecule targeted drug therapy targeting VEGF or VEGF receptor in the past 1 year;
  • Use of any biological product or live viral vaccine within 3 months prior to drug infusion, or use of any monoclonal antibody within 12 months;
  • Have hereditary bleeding tendency or coagulopathy, or have a history of thrombosis or bleeding;
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  • History of digestive tract perforation or fistula;
  • Unhealed wounds, ulcers or fractures, or those who had undergone major surgery within the previous 2 months or were expected to undergo major surgery within the study period or 2 months after the end of the study;
  • Use a prescription or over-the-counter drug or nutraceutical product within the 5 half-life of the drug or nutraceutical product or within 2 weeks prior to use of the study drug, whichever is longer. Herbal supplements should be discontinued 28 days prior to use of the study drug;
  • Hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody test positive;
  • Known allergy to bevacizumab or any of its excipients;
  • Known history of allergic diseases or allergies;
  • People with a history of severe allergy, allergy to protein products, rat-derived products and related ingredients of experimental drugs;
  • Blood donation history within 3 months prior to drug infusion;
  • Has received any other investigational drug treatment or participated in another interventional clinical trial within 3 months prior to screening;
  • History of alcohol or drug abuse in the 12 months prior to screening; Subjects were unable to abstain from alcohol within 72 hours prior to administration and throughout the trial;
  • A history of mental illness;
  • Have pregnancy plans during the trial ;
  • Unable to complete the study according to protocol requirements during the study;
  • Conditions considered unsuitable for inclusion by other researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Randomized, Double-blind, Parallel-controlled Phase I Clinical Study Comparing the Pharmacokinetics, Safety and Immunogenicity of SCT510 With Bevacizumab (Avastin®) in Chinese Healthy Males

This is a randomized, double-blind, parallel-controlled phase I clinical study comparing the pharmacokinetics, safety and immunogenicity of SCT510 with bevacizumab (Avastin®) in Chinese healthy males.

Read the detailed description

Eighty-four subjects randomly (1:1) received a 3 mg/kg dose of SCT510 or bevacizumab infusion for 90 min and followed up for 99 days. The screening period of this study is 14 days. Subjects will be admitted to the research center on day-1 and will be allowed to leave the research center with relevant observation and evaluation on day 5 (96 hours) after the completion of the administration. Subjects were asked to return for 10 follow-up visits respectively according to this research protocol, on the day 8, day 15, day 22, day 29, day 43, day 57, day 64, day 71, day 85 and day 99.

All subjects in each group will be blinded after blood/urine collection and safety evaluation.

Blood samples will be tested by a validated LC/MS method for pharmacokinetic study.

Conditions
Healthy
Being tested
SCT510, Bevacizumab
Keywords
pharmacokinetics, immunogenicity, biosimilar, phase I, anti-VEGF monoclonal antibody

What participants receive

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

  • SCT510Drug

    Subjects received a single intravenous infusion (3 mg/kg) of SCT510 for 90 minutes , and the volume of administration was calculated based on the subject's weight.

  • BevacizumabDrug

    Subjects received a single intravenous infusion (3 mg/kg) of bevacizumab for 90 minutes , and the volume of administration was calculated based on the subject's weight.

Study groups in NCT05113511
Study groupRoleWhat they receive
SCT510ExperimentalSCT510
Receives: Drug: SCT510
bevacizumabActive comparatorbevacizumab
Receives: Drug: Bevacizumab

What is being measured

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

  1. AUC0-inf

    area under the concentration-time curve from time zero (pre-dose) extrapolate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity

    Measured: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504，672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]

  2. AUC0-last

    area under the concentration-time curve from time zero (pre-dose) extrapolated to last quantifiable concentration (AUC0-t)

    Measured: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504，672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]

  3. Cmax

    Maximum Serum Concentration

    Measured: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504，672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]

Secondary outcomes (3)

  1. Tmax

    Time to Cmax

    Measured: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504，672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]

  2. Number of Participants With Anti-Drug Antibody Positive

    number of participants with anti-drug antibody positive at post-dose

    Measured: up to 99 days

  3. Number of Participants With neutralizing antibody Positive

    number of participants with neutralizing antibody positive at post-dose

    Measured: up to 99 days

Timeline

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

  1. First posted9 Nov 2021
  2. Study start9 May 2018
  3. Primary completion28 Nov 2018
  4. Study completion26 Jul 2021

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05113511
Sponsor's protocol ID
SCT510NSCLC01
Status last verified
Nov 2021
First submitted
8 Nov 2021
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hong Q, Jiao Y, Li D, Ma H, Wu K, Xie L. Population Pharmacokinetics of SCT510 (a Bevacizumab Biosimilar) and Avastin(R) in Healthy Subjects and Patients with Non-squamous Non-small Cell Lung Cancer. Clin Drug Investig. 2026 Feb;46(2):143-157. doi: 10.1007/s40261-025-01518-8. Epub 2026 Jan 6.

    PubMed 41495391

  • Wu J, Wu G, Xie L, Lv D, Xu C, Zhou H, Wu L, Zhang J, Shentu J. A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin(R)) in Healthy Chinese Males. Drugs R D. 2023 Jun;23(2):175-183. doi: 10.1007/s40268-023-00424-8. Epub 2023 May 29.

    PubMed 37247166

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCT510 and Bevacizumab in people with Healthy, run by First Affiliated Hospital of Zhejiang University 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 4 inclusion and 20 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 9 Nov 2021. 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-inf (time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504，672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]). The study lists 3 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 NCT05113511, which also lists 2 linked publications.

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 9 Nov 2021.

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