Clinical trials: Monoclonal
HIV Infections
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
- Trial name
- NCT02568215
- Testing
- VRC01
- Where
- 21 sites in Botswana, Kenya and 5 more
- Volunteers
- 1,924 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Multiple Myeloma, Multiple Myeloma Progression
CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and…
- Conditions
- Multiple Myeloma, Multiple Myeloma Progression, Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM)
- Trial name
- NCT06644625
- Testing
- Blood draw for the laboratory assessment
- Where
- United States
- Volunteers
- 1,665 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
COVID-19
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
- Trial name
- NCT04432298
- Testing
- Pamrevlumab
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Kyntra Bio
Tetanus
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus…
- Trial name
- NCT07149454
- Testing
- Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Human Tetanus Immunoglobulin
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005
Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
- Trial name
- NCT04220073
- Testing
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
HIV Infections
Observational Study of Blood Treated With Cytolin
Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.
- Trial name
- NCT01048372
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- CytoDyn, Inc.
Healthy Volunteers
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers.
- Trial name
- NI-0101-01 (NCT01808469)
- Testing
- Monoclonal antibody
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Light Chain Bioscience - Novimmune SA
Healthy
A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
To evaluate the safety and tolerability of a single IV dose of MEDI-557.
- Trial name
- NCT00578682
- Testing
- MEDI-557
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
COVID-19; and High Infection Risk of SARS-CoV-2
Tolerability,Safety,Pharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody (JS016) for Injection in Chinese Health Subjects
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese…
- Trial name
- NCT04441918
- Testing
- JS016 (anti-SARS-CoV-2 monoclonal antibody)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
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)
HIV Antibodies
Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Background: The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same.
- Trial name
- VRC 609 (NCT03538626)
- Testing
- VRC-HIVMAB091-00-AB, rHuPH20
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
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.
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)
Coronavirus Disease 2019(COVID-19)
Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
- Trial name
- NCT04483375
- Testing
- SCTA01
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Sinocelltech Ltd.
Acute Gout Flare
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare…
- Trial name
- NCT07295496
- Testing
- IBI3011
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Neural Dissimilarity in Patients With Chronic Rhinosinusitis With Nasal Polyps Treated With Biologics
This project will focus on rehabilitation of olfactory dysfunction in patients with chronic rhinosinusitis with polyps given biological treatment based on functional magnetic resonance imaging.
- Conditions
- Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Functional Magnetic Resonance Imaging (fMRI)
- Trial name
- NCT07819162
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Healthy Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
- Trial name
- NCT07222254
- Testing
- AZD0292
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
HIV-1 Infection, HIV Infection
DCVax Plus Poly ICLC in Healthy Volunteers
DCVax-001 is a recombinant protein vaccine designed to prevent and potentially treat human immunodeficiency virus (HIV) infection.
- Conditions
- HIV-1 Infection, HIV Infection, Healthy Volunteers
- Trial name
- NCT01127464
- Testing
- DCVax-001, Poly-ICLC
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Rockefeller University