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Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection

NCT04361812 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-11-21

No results posted yet for this study

Summary

To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.

Conditions

  • Similarity of Pharmacokinetics and Safety

Interventions

DRUG

HS632

Subcutaneous injection of HS632

DRUG

Omalizumab (Xolair®)

Subcutaneous injection of Omalizumab Xolair®)

Sponsors & Collaborators

  • BioRay Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jing Zhang, Dr. Pharm · Huashan Hospital

  • Xiaojie Wu, Dr. Pharm · Huashan Hospital

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
2020-10-15
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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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 NCT04361812 on ClinicalTrials.gov