Clinical trials: MAB
Healthy Subjects
A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon
This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.
- Trial name
- NCT07788807
- Testing
- Adalimumab, Guselkumab, SDL-001
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Surmount Services, Inc.
Thrombosis, Cerebral Ischemia
Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer
This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.
- Conditions
- Thrombosis, Cerebral Ischemia, Venous Thrombosis, Pulmonary Embolism
- Trial name
- TS23Phase1a (NCT03001544)
- Testing
- TS23
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Translational Sciences, Inc.
Malaria
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP).
- Trial name
- NCT05891236
- Testing
- MAM01 1.5 mg/kg, MAM01 5 mg/kg, MAM01 10 mg/kg
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Severe Asthma
3TR Asthma Biologics Cohort (ABC) Study
The 3TR-ABC study is a multicentre observational prospective cohort study platform that follows patients with severe asthma from the start of biological therapy and three years onwards.
- Trial name
- 3TR-ABC (NCT06126692)
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Malian Children
The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of…
- Trial name
- L9LS (NCT05304611)
- Testing
- L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection, L9LS (VRC-MALMAB0114-00-AB) intravenous injection
- Where
- 2 sites in Mali
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage, To Compare the Difference of Inflammasome Response of Inflammatory Macrophage
The Role of Inflammasome in Inflammatory Macrophage in Mycobacterium Avium Complex-lung Disease and Mycobacterium Abscessus-lung Disease
1. To investigate the inflammasome response of inflammatory and resting macrophage derived from healthy human participants by stimulation using MAC or MAB bacilli. 2.
- Conditions
- To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage, To Compare the Difference of Inflammasome Response of Inflammatory Macrophage, To Study the Diagnostic Aid From Immunological Markers in Inflammasome Response
- Trial name
- NCT02005094
- Where
- Taiwan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Rabies Virus Infection
Safety, Pharmacokinetics, and Pharmacodynamic Testing of Rabies mAb CBB 1
rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing…
- Trial name
- NCT05832073
- Testing
- Natural full human monoclonal antibody CBB 1 injection, Rabies Human Immunoglobulin (HRIG), Lyophilized rabies vaccine for human use (Vero cells)
- Where
- China
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Changchun BCHT Biotechnology Co.
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
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults
The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
- Trial name
- NCT05275660
- Testing
- HFB30132A
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HiFiBiO Therapeutics
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
Phase 1, Dengue
Safety Study of Dengushield in Healthy Adults
This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.
- Trial name
- NCT03883620
- Testing
- Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous, Dengushield 7 mg/kg (Cohort 3) intravenous
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Crohn's Disease, Ulcerative Colitis
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Healthy Controls
- Trial name
- NCT03397108
- Testing
- The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
- Where
- 2 sites in Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Healthy Participants
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Primary Objectives: Cohort A: To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: To evaluate the safety and…
- Trial name
- NCT04452318
- Testing
- REGN10933 + REGN10987
- Where
- 134 sites in United States, Moldova and 1 more
- Volunteers
- 3,303 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Atherosclerosis, Cardiovascular Diseases
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
The INTENSITY-LOW study aims to answer if there are any limits to LDL reduction in relation to benefitting vascular health from a mechanistic viewpoint, and therefore potentially limitations to primary prevention in healthy…
- Trial name
- NCT03273972
- Testing
- Written Informed Consent, Inclusion/Exclusion check, Full Clinical Chemistry and Haematology Bloods
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
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
Healthy Volunteers
Clinical Trial to Evaluate Pharmacokinetics,Safety and Immunogenicity of Single Injection of CDP1 to Healthy Volunteers Compared to Erbitux
Background Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and mortality of colorectal cancer in our country are on the rise.
- Trial name
- NCT03881787
- Testing
- anti-EGFR monoclonal antibody, Cetuximab injection
- Where
- 2 sites in China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Dragonboat Biopharmaceutical Company Limited
Healthy Participants Study
Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab
This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using…
- Trial name
- NCT05339100
- Testing
- Anifrolumab, Autoinjector, Accessorized Pre-Filled Syringe
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Similarity of Pharmacokinetics and Safety
Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection
To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects
- Trial name
- NCT05323981
- Testing
- HS627(210mg/7ml), HS627(420mg/14ml), Perjeta
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- BioRay Pharmaceutical Co., Ltd.