Xolair (omalizumab) / Novartis, Roche  >>  Phase 1
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13 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Xolair (omalizumab) / Roche, Novartis
ChiCTR2000031925: A multicenter, randomized, double-blind, parallel controlled phase I clinical trial comparing the pharmacokinetic and safety similarities of recombinant anti IgE humanized monoclonal antibody for injection(HS632) with Omalizumab (Xolair?)after a single dose administration in Chinese healthy subjects

Not yet recruiting
1
252
 
Subcutaneous injection of HS632 ;Subcutaneous injection of Omazumab
Huashan Hospital Affiliated to Fudan University; Shanghai Shuguang Hospital, Zhejiang Hisunbioray biopharmaceutical Co., Ltd.
Asthma
 
 
NCT04361812: Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection

Not yet recruiting
1
60
RoW
HS632, Recombinant anti IgE humanized monoclonal antibody 150mg, Omalizumab (Xolair®), Omalizumab 150mg
Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
Similarity of Pharmacokinetics and Safety
12/21
12/21
NCT05897008: The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity

Completed
1
114
RoW
CMAB007, Xolair
Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy Volunteers
06/22
09/22
ChiCTR2100047781: Phase i, single-center, randomized, double-blind, parallelity-controlled clinical trial comparing pharmacokinetic and safety comparability of recombinant anti-IgE humanized monoclonal antibody for injection (HS632) with omalizumab( Xolair) after single dose administration in healthy Chinese subjects

Not yet recruiting
1
62
 
Subcutaneous injection of HS632 ;Subcutaneous injection of Omazumab
The First Affiliated Hospital of Guangzhou University of Chinese Medicine; Zhejiang haizheng pharmaceutical co. LTD, self-raised
Asthma
 
 
NCT05449535: Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects

Completed
1
56
RoW
JYB1904, Omalizumab, Xolair, JYB1904 Placebo
Jemincare
Healthy
01/23
01/23
OMA-COMP-I, NCT06494345: A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

Completed
1
180
RoW
Genolair, solution for subcutaneous administration, 150 mg, Omalizumab biosimilar solution, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Omalizumab biosimilar lyophilisate, Xolair®, solution for subcutaneous administration, 150 mg, Omalizumab solution
AO GENERIUM
Allergic Asthma
06/24
06/24
NCT05413161: To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

Completed
1
306
RoW
ADL-018, US-licensed XOLAIR, EU-Approved XOLAIR
Kashiv BioSciences, LLC
Healthy
02/23
06/23
NCT05564611: PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects

Recruiting
1
204
RoW
Omalizumab 150mg, ADL-018
Kashiv BioSciences, LLC
Healthy
07/23
08/23
NCT05053334: Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair

Completed
1
165
RoW
Omalizumab Prefilled Syringe
Syneos Health, CuraTeQ Biologics Private Ltd.
Healthy Volunteers
11/23
11/23
CRSwNP, NCT04583501: Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Completed
1
21
US
Omalizumab
Johns Hopkins University, Genentech, Inc.
Chronic Rhinosinusitis With Nasal Polyps, Nasal Polyps
07/24
07/24
STRING, NCT04943744: Gastrointestinal Test With Oral Immunotherapy

Terminated
1
13
US
Entero-tracker, omalizumab, dupliumab
Stanford University
Eosinophilic Disorder, Food Allergy
05/24
05/24
NCT05564221: A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

Active, not recruiting
1
46
RoW
YH35324, Placebo, Omalizumab, Xolair® prefilled syringe 150 for injection
Yuhan Corporation
Atopic Healthy Subjects, Adult Subjects With Allergic Diseases
12/24
12/24
NCT05960708: A Single Dose, Phase 1 Study of YH35324 in Patients With Various Allergic Diseases

Completed
1
30
RoW
YH35324, Omalizumab, Xolair® prefilled syringe 150 for injection, Placebo
Yuhan Corporation
Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria
09/24
09/24

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