Clinical trials: Monoclonal Antibody
Healthy Participants
An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab
The purpose of this study is to compare the pharmacokinetic (PK) exposures of a single subcutaneous (SC) dose of tozorakimab administered using AI or APFS in healthy participants.
- Trial name
- NCT06908577
- Testing
- Tozorakimab, Autoinjector (AI) Device, Accessorised Prefilled Syringe (APFS) Device
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Alzheimer Disease, Cognitive Dysfunction
A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease
The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.
- Conditions
- Alzheimer Disease, Cognitive Dysfunction, Dementia
- Trial name
- Autonomy (NCT04619420)
- Testing
- JNJ-63733657
- Where
- 122 sites in United States, Australia and 8 more
- Volunteers
- 523 people
- Sponsor
- Janssen Research & Development, LLC
Locally Advanced Breast Cancer, Triple Negative Breast Cancer
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and…
- Conditions
- Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
- Trial name
- NCT06449222
- Testing
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 83 people
- Sponsor
- BioNTech SE
Chronic Plaque Psoriasis
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.
- Trial name
- VIP-S (NCT02690701)
- Testing
- Secukinumab 300 mg
- Where
- 12 sites in United States
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
A Clinical Study to Evaluate SM17 for Atopic Dermatitis
This trial is a phase 2, randomized, double-Blind, placebo-Controlled, dose-finding clinical study conducted in participants with moderate-to-severe atopic dermatitis.
- Trial name
- NCT07445919
- Testing
- SM17 for subcutaneous injection
- Where
- China
- Volunteers
- 200 people
- Sponsor
- SinoMab BioScience Ltd
Healthy
Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults
The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants.
- Trial name
- NCT04590430
- Testing
- HFB30132A
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- HiFiBiO Therapeutics
Treatment of Acute Zika Virus Infection
Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in Humans
Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector that transmits Dengue virus, Aedes aegypti.
- Trial name
- NCT03443830
- Testing
- Tyzivumab
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tychan Pte Ltd.
Rheumatoid Arthritis
VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly…
- Trial name
- VELVET (NCT01390545)
- Testing
- Veltuzumab
- Where
- 63 sites in United States, Argentina and 9 more
- Volunteers
- 300 people
- Sponsor
- Takeda
Autoimmune Diseases
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)
This study aims to evaluate the safety, tolerability and PK of repeat dose administration of GSK2618960 in the treatment of pSS.
- Trial name
- NCT03239600
- Testing
- GSK2618960 2 mg/kg, Methotrexate
- Where
- United Kingdom
- Sponsor
- GlaxoSmithKline
Advanced Malignancy, Advanced Solid Cancers
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Cancers, Metastatic Solid Tumors
- Trial name
- NCT07238075
- Testing
- ADCX-020
- Where
- 9 sites in Australia, Spain
- Volunteers
- 290 people
- Sponsor
- Adcytherix SAS
Rheumatoid Arthritis
First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts
This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a…
- Trial name
- NCT05576012
- Testing
- SOL-116
- Where
- 2 sites in Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Lipum AB
Systemic Lupus Erythematosus
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
- Trial name
- NCT00660881
- Testing
- Epratuzumab
- Where
- 42 sites in United States, Belgium and 9 more
- Volunteers
- 210 people
- Sponsor
- UCB Pharma
Cancer, Neoplasm Metastasis
Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.
- Trial name
- NCT00492830
- Testing
- TRC093 recombinant humanized IgG1k monoclonal antibody
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Solid Tumor
Pharmacokinetics and Tolerancebility Studies of Gentuximab Injection in the Treatment ofPatients With Late Recurrence of Metastatic Solid Tumors in China
The primary objective is to evaluate the safety and, tolerabilitytolerance, pharmacokinetices and immunogenicity of escalating single doses and subsequent multiple dose of Gentuximab Injection in patients with late recurrence of…
- Trial name
- NCT03313219
- Testing
- Gentuximab Injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Plasma Cell Myeloma
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and…
- Trial name
- IMROZ (NCT03319667)
- Testing
- Isatuximab SAR650984, Bortezomib, Lenalidomide
- Where
- 104 sites in United States, Australia and 19 more
- Volunteers
- 475 people
- Sponsor
- Sanofi
Non Small Cell Lung Cancer
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy…
- Trial name
- INSPIRE (NCT00982111)
- Testing
- Pemetrexed, Cisplatin, Necitumumab
- Where
- 101 sites in United States, Australia and 18 more
- Volunteers
- 633 people
- Sponsor
- Eli Lilly and Company
Psoriasis
AMG 714 20060349 Multiple Dose Study in Moderate to Severe Psoriasis Subjects
Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy.
- Trial name
- NCT00443326
- Testing
- AMG 714
- Volunteers
- 22 people
- Sponsor
- Amgen
Healthy
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used…
- Trial name
- NCT02912247
- Testing
- human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, adalimumab
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Myeloma Multiple
A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)
The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple…
- Trial name
- AMMADINA (NCT07742215)
- Testing
- BCD-248 + daratumumab, Daratumumab + pomalidomide + dexamethasone
- Where
- 16 sites in Belarus, Russia
- Volunteers
- 390 people
- Sponsor
- Biocad
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
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