Who is sponsoring NCT04361812?

NCT04361812 is sponsored by BioRay Pharmaceutical Co., Ltd..

What drugs are being tested in NCT04361812?

Interventions in NCT04361812: HS632, Omalizumab (Xolair®).

What condition does NCT04361812 study?

NCT04361812 studies Similarity of Pharmacokinetics and Safety.

Is NCT04361812 still recruiting?

NCT04361812 is currently terminated. Last updated 21 November 2025.

Last reviewed 2025-11-21 · How we verify

NCT04361812

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 21 November 2025

What this trial tests

Phase 1 trial testing HS632 in Similarity of Pharmacokinetics and Safety in 1 participant. Terminated before completion.

Timeline

15 October 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	BioRay Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1
Start date	15 October 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

HS632 — full drug profile →
Omalizumab (Xolair®)

Conditions studied

Similarity of Pharmacokinetics and Safety — all drugs for Similarity of Pharmacokinetics and Safety →

Sponsor

BioRay Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 40, male only, with Similarity of Pharmacokinetics and Safety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other BioRay Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07498647 — Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia · Phase 2 · not yet recruiting
NCT06937957 — A Study of BR111 in Patients With Advanced Malignancies · Phase 1 · recruiting
NCT06642909 — A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy · Phase 2 · active not recruiting
NCT06289894 — A Study of BRY805 in Participants With Advanced Solid Tumors · Phase 1 · terminated
NCT06126718 — Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04361812 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioRay Pharmaceutical Co., Ltd.
Last refreshed: 21 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04361812.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing