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Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection

NCT05323981 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-07-11

No results posted yet for this study

Summary

To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects

Conditions

  • Similarity of Pharmacokinetics and Safety

Interventions

DRUG

HS627(210mg/7ml)

Intravenous drip of 420mg HS627

DRUG

HS627(420mg/14ml)

Intravenous drip of 420mg HS627

DRUG

Perjeta

Intravenous drip of 420mg PERJETA

Sponsors & Collaborators

  • BioRay Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2022-10-09
Completion
2022-10-09

Countries

  • China

Study Locations

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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 NCT05323981 on ClinicalTrials.gov