PK and Safety of SCT510

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT05113511
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 9, 2021
Start date
May 9, 2018
Status verified
Nov 2021
Primary completion
Nov 28, 2018
Completion
Jul 26, 2021

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCT510
    SCT510
  • Active Comparator: bevacizumab
    bevacizumab

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 ] ]

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