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PK and Safety of SCT510

NCT05113511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-11-09

No results posted yet for this study

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

Interventions

DRUG

SCT510

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.

DRUG

Bevacizumab

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.

Sponsors & Collaborators

  • Sinocelltech Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2018-11-28
Completion
2021-07-26

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113511 on ClinicalTrials.gov