Clinical Trials Sponsored by Biomedis International Ltd

Total 322 results

Biomedis International Ltd.

Unknown

Recurrent Stroke Prevention Clinical Outcome Study (RESPECTS)

Stroke | Hypertension | Blood Pressure

Japan
Osteros Biomedica Ltd

Completed

A Trial of MBC-11 in Patients With CIBD

Bone Metastasis
Prima BioMed Ltd

Completed

Ovarian Cancer Vaccine for Patients in Remission

Epithelial Ovarian Cancer

United States, Australia
Prima BioMed Ltd

Withdrawn

Cvac as Maintenance Treatment Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

Pancreatic Carcinoma Stage I | Pancreatic Carcinoma Stage II
Prima BioMed Ltd

Terminated

Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment (CANVAS)

Epithelial Ovarian Cancer

United States, Australia
Remedor Biomed Ltd

Completed

Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers (Remede d'Or)

Diabetic Foot Ulcer

Israel
Prima BioMed Ltd

Completed

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)

Epithelial Ovarian Cancer

United States, Australia
Samsung Bioepis Co., Ltd.

Recruiting

A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy

Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage II

Korea, Republic of, Poland, Spain
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Healthy

France, United States
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

Healthy

Belgium
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Lung Cancer | Non-small Cell Lung Cancer

Korea, Republic of, Germany, Hungary, Taiwan, Thailand, Georgia, Serbia, Poland, Romania, Ukraine, Spain, Belarus, Russian Federation
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer

HER2 Positive Early or Locally Advanced Breast Cancer

Czechia
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Poland, United Kingdom
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Lithuania, Poland
Samsung Bioepis Co., Ltd.

Recruiting

A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Stage IV

Georgia, India, Romania, Spain
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Paroxysmal Nocturnal Hemoglobinuria

Korea, Republic of, Taiwan, Malaysia, Thailand, Romania, India, Mexico, Ukraine
Samsung Bioepis Co., Ltd.

Terminated

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

Breast Neoplasms

Ukraine, Romania, Russian Federation, France, Bulgaria, Czechia, Poland
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Psoriasis | Moderate to Severe Plaque Psoriasis

Czechia, Estonia, Hungary, Korea, Republic of, Latvia, Lithuania, Poland, Ukraine
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects

Healthy

France
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Age-Related Macular Degeneration

Korea, Republic of, United States, India, Germany, Hungary, United Kingdom, Czechia, Poland, Russian Federation
Samsung Bioepis Co., Ltd.

Completed

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Poland
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Healthy

Belgium, New Zealand
Samsung Bioepis Co., Ltd.

Completed

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Poland
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Bulgaria, Lithuania
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Neovascular Age-related Macular Degeneration

Czechia, Estonia, Hungary, Korea, Republic of, Latvia, Poland, United States, Croatia, Japan, Russian Federation
Samsung Bioepis Co., Ltd.

Completed

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Macular Edema | Retinal Vein Occlusion | Neovascular Age-related Macular Degeneration

Poland
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis

Poland
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

A Phase I Study of SB26 in Healthy Volunteers

Healthy Volunteers

United States
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Healthy

Netherlands
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Healthy

Germany
UnicoCell Biomed CO. LTD

Recruiting

Efficacy and Safety of ELIXCYTE Intra-articular Injection in Subject With Knee Osteoarthritis

Knee Osteoarthritis

Taiwan
Vitaflo International, Ltd

Completed

Evaluation of PKU Sphere Liquid

Phenylketonurias

United Kingdom
Vitaflo International, Ltd

Completed

Use of Betashot in Children and Adults With Epilepsy

Nervous System Disorder

United Kingdom
Vitaflo International, Ltd

Completed

Evaluation of TYR Sphere

Alkaptonuria | Tyrosinemias | Tyrosinemia, Type I | Tyrosinemia, Type II | Tyrosinemia, Type III

United Kingdom
Vitaflo International, Ltd

Completed

Evaluation of Keyo in Children With Epilepsy (Keyo)

Intractable Epilepsy | Glucose Transporter Type 1 Deficiency Syndrome | Ketogenic Dieting

United Kingdom
Vitaflo International, Ltd

Completed

Evaluation of Ketoflo (Ketoflo)

Glucose Transporter Type 1 Deficiency Syndrome | Ketogenic Dieting | Epilepsy Intractable

United Kingdom
Linepharma International LTD

Recruiting

Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion (MiMAC)

Medical Abortion

Canada
Vitaflo International, Ltd

Completed

Evaluation of PKU Start (PKU Start)

Phenylketonuria | Inborn Errors of Metabolism

United Kingdom
Vitaflo International, Ltd

Completed

Evaluation of Renastep (Renastep)

Chronic Kidney Diseases | Renal Disease

United Kingdom
Vitaflo International, Ltd

Withdrawn

Evaluation of Krio in Children and Adults With Epilepsy (Krio)

Epilepsy | Glucose Transporter Type 1 Deficiency Syndrome | Ketogenic Dieting
Vitaflo International, Ltd

Completed

Evaluation of PKU Sphere in Italy

Phenylketonurias | PKU

Italy
Vitaflo International, Ltd

Recruiting

Evaluation of the Express Plus Range (express plus)

Phenylketonurias | PKU | Maple Syrup Urine Disease | Homocystinuria | Glutaric Acidemia I | Hereditary Tyrosinemia

United Kingdom
Vitaflo International, Ltd

Completed

A Multicenter Study to Evaluate the Nutritional Suitability of Renastart (Renastart)

Chronic Kidney Disease | Hyperkalemia

Germany
Vitaflo International, Ltd

Completed

Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet (ZestiVits)

Deficiency of Micronutrients

United Kingdom
Vitaflo International, Ltd

Active, not recruiting

Evaluation of PKU Explore France

Phenylketonurias

France

Clinical Trials Sponsored by Biomedis International Ltd

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