PK and Safety of SCT510

NCT05113511 | Completed Phase 1 DMC

• 1 other identifier: SCT510NSCLC01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

pharmacokinetics; immunogenicity; biosimilar; phase I; anti-VEGF monoclonal antibody

Outcome Measures

Primary Outcomes (3)

• 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

  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 ]

• AUC0-last

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

  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 ]

• Cmax

  Maximum Serum Concentration

  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)

• Tmax

  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 ]

• Number of Participants With Anti-Drug Antibody Positive

  up to 99 days

• Number of Participants With neutralizing antibody Positive

  up to 99 days

Study Arms (2)

SCT510

EXPERIMENTAL

SCT510

Drug: SCT510

bevacizumab

ACTIVE COMPARATOR

bevacizumab

Drug: Bevacizumab

Interventions

SCT510 DRUG

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.

SCT510

Bevacizumab DRUG

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.

bevacizumab

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Sinocelltech Ltd.: collaborator

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

• 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 Jan 6. doi: 10.1007/s40261-025-01518-8. Online ahead of print.

  PMID: 41495391 DERIVED

• 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.

  PMID: 37247166 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.(Pharm）

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 9, 2021
• Study Start: May 9, 2018
• Primary Completion: November 28, 2018
• Study Completion: July 26, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)