Clinical trials: MAB
Influenza, Human
Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
The purpose of this study is to compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo.
- Trial name
- NCT01390025
- Testing
- TCN-032
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Theraclone Sciences, Inc.
Healthy Adult Male
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057…
- Trial name
- NCT07181694
- Testing
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL, Adalimumab (Humira) 100 mg/mL
- Where
- 4 sites in Russia
- Volunteers
- 444 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Volunteers
Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
- Trial name
- NCT02452996
- Testing
- GNbAC1
- Where
- Germany
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- GeNeuro Innovation SAS
Healthy Volunteers
Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland)…
- Trial name
- NAP (NCT04601389)
- Testing
- Omalizumab (JSC "GENERIUM", the Russian Federation), Xolair® (Novartis Pharma AG, Switzerland)
- Where
- 2 sites in Russia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
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
Enterovirus Infection
Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers.
- Trial name
- NCT06444048
- Testing
- EV68-228-N
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rabies
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children…
- Trial name
- NCT00708084
- Testing
- CL184, HRIG
- Where
- Philippines
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
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
Herpes Simplex Keratitis
The Efficacy of Two Potential Diagnostic Assays for Herpes Simplex Keratitis (HSK)
The aim of this study is to compare the safety, specificity, sensitivity and ease of procedure of two potential diagnostic assays for HSV-1 detection in the cornea.
- Trial name
- NCT00357812
- Where
- 3 sites in United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Healthy
A Preliminary Study to Evaluate PF-07264660 in Healthy Participants
The purpose of this clinical trial is to learn about the safety and effects of study medicine PF-07264660 compared to a placebo. This is the first study of PF-07264660 in humans.
- Trial name
- NCT05496738
- Testing
- PF-07264660 intravenous single ascending dose, PF-07264660 subcutaneous multiple ascending dose
- Where
- 6 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections
A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.
- Trial name
- NCT03205917
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Healthy
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19
The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events…
- Trial name
- NCT05293678
- Testing
- REGN15160 (IV), REGN15160 (SC)
- Where
- Belgium
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Healthy, Plaque Psoriasis
A Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis.
This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body.
- Trial name
- NCT06143371
- Testing
- CAN10
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Plasmodium Falciparum Infection, Malaria
L9LS MAb in Malian Adults
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf)…
- Trial name
- NCT05816330
- Testing
- L9LS (VRC-MALMAB0114-00-AB)
- Where
- 3 sites in Mali
- Volunteers
- 490 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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.
HIV Infection, Monoclonal Antibody, Human
Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults
Background: VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection.
- Conditions
- HIV Infection, Monoclonal Antibody, Human, HIV Antibodies, VRC01 Monoclonal Antibody
- Trial name
- NCT01993706
- Testing
- VRC-HIVMAB060-00-AB
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer
Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults
The aim of this clinical trial is to see how safe and tolerable the clinical trial drug (REGN9533) is in healthy participants. This is the first time that REGN9533 will be given to humans.
- Trial name
- NCT06665828
- Testing
- REGN9533
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
HIV
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing…
- Trial name
- NCT06812494
- Testing
- VRC07-523LS 400mg, PGT121.414.LS 400mg, PGDM1400LS 400mg
- Where
- 17 sites in United States, Brazil and 1 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmune Disease
Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy participants.
- Trial name
- NCT05894707
- Testing
- SCT650C
- Where
- 3 sites in Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sinocelltech Ltd.