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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Completed | 1 | 21 | US | Omalizumab | Johns Hopkins University, Genentech, Inc. | Chronic Rhinosinusitis With Nasal Polyps, Nasal Polyps | 07/24 | 07/24 | | |
| 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 |
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| 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 |
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| 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 | | |