Clinical trials: Intravenous Immunoglobulin
Infectious Diseases, Influenza
Development of Immune Globulin Treatment for Avian Flu
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza…
- Conditions
- Infectious Diseases, Influenza, Avian Flu
- Trial name
- NCT00383071
- Testing
- H5N1 vaccine, Apheresis
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV-2 Infection
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals.
- Trial name
- NCT04631666
- Testing
- DZIF-10c
- Where
- Germany
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of Cologne
SARS-CoV-2 Infection
A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults
The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously…
- Trial name
- NCT05142306
- Testing
- COVID-HIG
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Ebola Virus Disease, Marburg Virus Disease
Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Primary Objective: To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.
- Trial name
- NCT04723602
- Testing
- cAd3-Marburg, cAd3-EBO-S
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Albert B. Sabin Vaccine Institute
Inhalational Anthrax
Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers
To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.
- Trial name
- NCT01932242
- Testing
- ETI-204
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Healthy Volunteer
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.
- Trial name
- NCT01620931
- Testing
- RO5469754
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Guillain-Barre Syndrome
Mini-pool Intravenous Immunoglobulin (MP-IVIG) in Guillain-Barré Syndrome
1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG) 2. to determine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the complications of Guillain-Barré syndrome…
- Trial name
- NCT04550611
- Testing
- Mini-pool Intravenous Immunoglobulin (MP-IVIG), plasma exchange
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Assiut University
Covid19
Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial
The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime.
- Trial name
- NCT04548557
- Testing
- intravenous immunoglobulin therapy
- Where
- Pakistan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Health Sciences Lahore
Healthy
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).
- Trial name
- NCT02246855
- Testing
- Gammaplex® (Human Normal Immunoglobulin)
- Where
- United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bio Products Laboratory
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or…
- Trial name
- NCT04212091
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
Adrecizumab Phase 1 Trial
This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.
- Trial name
- NCT02991508
- Testing
- Adrecizumab
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Pharmacokinetics of ASKP1240, Healthy Volunteers
Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects
The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.
- Trial name
- NCT01565681
- Testing
- ASP1240
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
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.
Smallpox Vaccine Adverse Reaction
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Objectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers.
- Trial name
- NCT02443623
- Testing
- Vaccination with ACAM2000
- Where
- Canada
- Volunteers
- 3,032 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Pulmonary Arterial Hypertension PAH
Study of Intravenous ZMA001 in Healthy Subjects
Background: A number of diseases can cause a type of lung injury called pulmonary arterial hypertension (PAH). Most people who develop PAH do not survive more than a few years. A new study drug (ZMA001) may help.
- Trial name
- NCT05967299
- Testing
- ZMA001 (BC-NKA-20008)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Drug-Related Side Effects and Adverse Reactions
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body, and by itself, has no pharmacological action.
- Trial name
- NCT02829307
- Testing
- 89Zr-GSK3128349 1 mg
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
- Trial name
- NCT01459562
- Testing
- NI-0501
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Influenza, Flu
A Phase 1, Open Label, Ascending Dose Cohort Study of the Pharmacokinetics of Anti-Influenza Hyperimmune Intravenous Immunoglobulin in Healthy Subjects
Despite currently available antivirals, influenza causes significant morbidity and mortality, with 226,000 excess hospitalizations and 30,000-50,000 deaths each year in the United States alone, and more therapies are needed in…
- Trial name
- NCT02037282
- Testing
- Anti-influenza IVIG
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Streptococcal Pharyngitis
Stopping Strep Throat With Antibodies in Healthy Adults.
This research group has previously established a safe and reliable model of experimental human streptococcal pharyngitis (a 'strep throat' human challenge model).
- Trial name
- CHIVAS-IgG (NCT07864350)
- Testing
- Streptococcus pyogenes M1 challenge strain, Intravenous immunoglobulin (IVIG)
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute
Migraine Disorders
Safety Tolerability and Pharmacokinetics of ALD403
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
- Trial name
- NCT01579383
- Testing
- ALD403, Sumatriptan
- Where
- Australia
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Alder Biopharmaceuticals, Inc.