Clinical trials: Monoclonal
Rheumatoid Arthritis
A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people.
- Trial name
- NCT02460393
- Testing
- Humanized TNFα monoclonal antibody
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Methamphetamine Abuse
Safety Study of Ch-mAb7F9 for Methamphetamine Abuse
The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and…
- Trial name
- NCT01603147
- Testing
- normal saline, ch-mAb7f9
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- InterveXion Therapeutics, LLC
Absolute Bioavailability
Absolute Bioavailability of Reslizumab in Healthy Subjects
The primary objective of this study is to assess the absolute bioavailability of reslizumab following administration of a single subcutaneous (sc) dose to healthy non-Japanese participants
- Trial name
- NCT01990443
- Testing
- Reslizumab IV, Reslizumab SC
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Prevention of Chikungunya Virus Infection
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects.
- Trial name
- NCT03829384
- Testing
- mRNA-1944
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Staphylococcus Aureus
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects
This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult…
- Trial name
- NCT01769417
- Testing
- MEDI4893
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Inhalational Anthrax
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin
- Trial name
- NCT01952444
- Testing
- ETI-204, Ciprofloxacin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects.
- Trial name
- NCT04445038
- Testing
- 610
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
West Nile Virus
A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults
The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous (IV) infusion to healthy adults.
- Trial name
- NCT00515385
- Testing
- MGAWN1
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- MacroGenics
Monoclonal Gammopathy of Undetermined Significance
Iceland Screens, Treats or Prevents Multiple Myeloma
This study will assess the benefits and harms of screening for monoclonal gammopathy of undetermined significance (MGUS). The overall and disease-specific mortality will be compared between screened and not screened participants.
- Trial name
- iStopMM (NCT03327597)
- Testing
- Clinical follow-up 1, Mental Health and Quality of Life questionnaire, Standard follow-up or treatment.
- Where
- Iceland
- Volunteers
- 80,761 people, healthy volunteers welcome
- Sponsor
- University of Iceland
Thromboangiitis Obliterans (Buerger's Disease)
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
This study is a first-in-human clinical trial of drug ATI-1013, in healthy adult cigarette smokers. The main questions it aims to answer are to learn about the safety of drug ATI-1013, how long drug ATI-1013 remains within the…
- Trial name
- NCT07215923
- Testing
- ATI-1013 (0.2 g), ATI-1013 (0.8 g), ATI-1013 (3.2 g)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Antidote Therapeutics, Inc
COVID-19 Virus Disease
Study to Evaluate the Safety and Concentrations of Monoclonal Antibody Against Virus That Causes COVID-19 Disease.
A Phase I dose-escalation study to test a new monoclonal antibody (called MAD0004J08) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19 disease.
- Trial name
- MAD0004J08 (NCT04932850)
- Testing
- MAD0004J08
- Where
- 2 sites in Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Toscana Life Sciences Sviluppo s.r.l.
Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS)
Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
the main objectives are 1. to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and 2.
- Trial name
- KIR3DL2 (NCT03322618)
- Testing
- blood samples
- Where
- France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Assistance Publique Hopitaux De Marseille
Healthy, HIV
A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117
The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected…
- Trial name
- NCT02018510
- Testing
- 1 mg/kg, single dose IV administration of 3BNC117, 3 mg/kg, single dose IV administration of 3BNC117, 10 mg/kg, single dose IV administration of 3BNC117
- Where
- 4 sites in United States, Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
HIV Infections
Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected…
- Trial name
- NCT03387150
- Testing
- VRC07-523LS
- Where
- 7 sites in United States, Switzerland
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Ebola Virus Disease
Prophylaxis Vaccine Antibodies Ebola
Three measures are currently being implemented to control Ebola outbreaks: Monitoring of contacts Isolation and treatment of sick people Vaccination of the population in high-risk areas.
- Trial name
- PROVAE (NCT04822376)
- Testing
- ansuvimab, Ervebo
- Where
- Guinea
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose…
- Trial name
- NCT06652958
- Testing
- VH4527079
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Volunteer
A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants
- Trial name
- NCT06955741
- Testing
- BMS-986446 IV, BMS-986446 SC, Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Alzheimer Disease
A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI…
- Trial name
- NCT06247345
- Testing
- ADEL-Y01 - healty participants, ADEL-Y01 - MCI/AD
- Where
- 6 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Alzheimer's Disease Expert Lab (ADEL), Inc.
Rheumatoid Arthritis, Juvenile
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis
The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).
- Trial name
- NCT00036374
- Testing
- Infliximab
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.
Influenza
Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses
The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.
- Trial name
- NCT01756950
- Testing
- 2 mg/kg CR8020, 5 mg/kg CR8020, 15 mg/kg CR8020
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV