Search clinical trials for: US-sourced DARZALEX®

Total 78 results

Shanghai Henlius Biotech

Active, not recruiting

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects

Multiple Myeloma

China
Samsung Bioepis Co., Ltd.

Completed

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

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

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

Healthy

Germany
Cipla BioTec Pvt. Ltd.
Quintiles, Inc.

Unknown

PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US) (CBT124NHV001)

Healthy

New Zealand
Shanghai Henlius Biotech

Completed

A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects

Healthy

China
Samsung Bioepis Co., Ltd.

Completed

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

Healthy

Belgium
EirGenix, Inc.

Completed

A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers

Healthy
mAbxience Research S.L.

Completed

A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva

Healthy Volunteers

Poland
Momenta Pharmaceuticals, Inc.
Mylan Inc.

Completed

Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects

Healthy Volunteers

United Kingdom
Enzene Biosciences Ltd.
Alkem Laboratories Ltd

Recruiting

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Healthy Male Subjects

Bulgaria, Poland
Shanghai Henlius Biotech

Recruiting

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects

Healthy Male Volunteers

China
Boehringer Ingelheim

Completed

Pharmacokinetics and Safety in Healthy Volunteers

Healthy

Belgium, New Zealand
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, Turkey
Bio-Thera Solutions

Completed

Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects

NSCLC

New Zealand
mAbxience Research S.L.

Unknown

A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and USlicensed Avastin®.

Healthy Volunteers

New Zealand
National Institute of Allergy and Infectious Diseases...
PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)

Recruiting

Daratumumab in Primary Antiphospholipid Syndrome (DARE-APS)

Autoimmune Disorders

United States
Boehringer Ingelheim

Terminated

A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food

Healthy

Germany
Asahi Kasei Pharma Corporation

Completed

Collagenase Option for Reduction of Dupuytren's Contracture in Japan (CORD-J)

Dupuytren's Contracture

Japan
New York Medical College

Recruiting

Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma (ALLO-T-DART)

T-cell Acute Lymphoblastic Leukemia | T-Cell Acute Lymphoblastic Lymphoma

United States
Genmab

Recruiting

GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

Acute Myeloid Leukemia (AML) | Diffuse Large B Cell Lymphoma (DLBCL) | Relapsed or Refractory Multiple Myeloma (RRMM)

United States, Korea, Republic of, Netherlands, Denmark, Australia, New Zealand, Poland, Spain, Sweden, Czechia, Malaysia, Greece, Moldova, Republic of, Georgia, Ukraine, France, Hungary, North Macedonia, Bosnia and Herzegovina
Qilu Pharmaceutical Co., Ltd.

Not yet recruiting

A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults

Tumor

China
UNC Lineberger Comprehensive Cancer Center

Completed

Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer

Kidney Cancer

United States
Samsung Bioepis Co., Ltd.

Completed

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

Healthy

Germany
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer

Completed

A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

Neutropenia (Low White Blood Cell Count)

United States
Barry A. Boilson
Janssen Biotech, Inc.

Enrolling by invitation

Daratumumab in HLA Desensitization Prior to Transplantation

Cardiac Transplant

United States
Manuel C. Vallejo

Completed

A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

Obesity

United States
Kamada, Ltd.

Completed

Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects (KAMRAB-003)

Rabies

United States
Merck Sharp & Dohme LLC

Withdrawn

Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)

Multiple Myeloma

United States, Canada, France, Israel, Spain, Sweden
BioFactura Australia Pty Ltd.
Avance Clinical Pty Ltd.

Completed

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults

Psoriasis

Australia, New Zealand
Shanghai Henlius Biotech

Completed

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects

Healthy Male Volunteers

China
Xentria, Inc.

Not yet recruiting

Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

Healthy Participants
mAbxience Research S.L.

Completed

Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.

Healthy Volunteers

Australia, New Zealand
Regeneron Pharmaceuticals

Recruiting

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Multiple Myeloma

United States, Spain, France, Greece
New York Institute of Technology
Stony Brook University

Unknown

Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease

Parkinson's Disease

United States
Boehringer Ingelheim

Completed

BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Spain, United States, Korea, Republic of, Malaysia, Poland, Thailand, Bulgaria, Chile, Estonia, Germany, Hungary, New Zealand, Russian Federation, Serbia, Ukraine
Dana-Farber Cancer Institute
Novartis Pharmaceuticals

Completed

Everolimus for Cancer With TSC1 or TSC2 Mutation

Tuberous Sclerosis Complex | TSC1 | TSC2 | MTOR

United States
Gan and Lee Pharmaceuticals, USA

Completed

PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Diabetes Mellitus, Type 1

Germany
Société Française d'Endoscopie Digestive

Completed

Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy (BIB)

Biliary Stricture | Jaundice, Obstructive

France
Seqirus

Completed

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

Influenza

United States
Qilu Pharmaceutical Co., Ltd.

Recruiting

A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Adults

Tumor

China
Celgene

Not yet recruiting

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)

Multiple Myeloma

China, Australia, United States, Argentina, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Norway, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom
Gan and Lee Pharmaceuticals, USA

Completed

PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

Diabetes Mellitus

Germany
Medical University of Vienna

Completed

Effect of Retaron® on Oxygen Induced Retinal Vasoconstriction in LPS Induced Inflammatory Model in Humans

Healthy Subjects | Imparied Retinal Vascular Reactivity

Austria
Bausch Health Americas, Inc.
Bausch & Lomb Incorporated

Completed

EYEFILL® C. -US Viscoelastic Clinical Investigation

Cataract

United States
Pfizer

Completed

A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

Healthy

United States
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer

Completed

A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

Neutropenia (Low White Blood Cell Count)

United States
Amgen

Completed

Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

Arthritis, Rheumatoid

United States, Germany, Bulgaria, Hungary, Poland, Estonia
Sandoz

Completed

Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa (ACCESS)

Anemia | Chronic Kidney Disease (CKD)

United States
Shanghai Henlius Biotech

Completed

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus Avastin® in Healthy Male Subjects

Healthy Male Subjects

China
Molnlycke Health Care AB

Completed

Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia

Inadvertent Perioperative Hypothermia | Preoperative Anxiety Experienced by the Patient

Germany, United Kingdom, Norway

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