Clinical trials: Intravenous Immunoglobulin
Systemic Amyloidosis
A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis
This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic…
- Trial name
- NCT05951816
- Testing
- 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m., 99mTc-Pyrophosphate
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Tennessee Graduate School of Medicine
Influenza
Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus
The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal antibody against influenza A viruses.
- Trial name
- NCT01406418
- Testing
- CR6261 2 mg/kg, CR6261 5 mg/kg, CR6261 15 mg/kg
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Hematological Malignancy
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).
- Trial name
- NCT01084252
- Testing
- Isatuximab SAR650984, Dexamethasone
- Where
- 59 sites in United States, Argentina and 15 more
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Dose Escalation Study of PF-06741086 In Healthy Subjects
This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
- Trial name
- NCT02531815
- Testing
- PF-06741086
- Where
- Belgium
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dermatitis, Atopic
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive
This study is divided into two parts: Part A of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamic (PD) effect of a single…
- Trial name
- NCT05590338
- Testing
- GSK1070806
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects and Atopic Dermatitis Subjects
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
The purpose of the study is to determine safety and tolerability of IL-31 mAB
- Trial name
- NCT01614756
- Testing
- BMS-981164
- Where
- 4 sites in United Kingdom
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Symptoms of Inhalational Anthrax
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments.
- Trial name
- NCT00448253
- Testing
- NP-015
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Heart Failure
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Primary Trial objectives: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose…
- Trial name
- COR-1-01 (NCT01043146)
- Testing
- COR-1
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Corimmun GmbH
Healthy
A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
- Trial name
- NCT02220153
- Testing
- UCB7665 Intravenous 1, UCB7665 Intravenous 2, UCB7665 Intravenous 3
- Where
- United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- UCB Celltech
Healthy Subjects, Cold Urticaria
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.
- Conditions
- Healthy Subjects, Cold Urticaria, Symptomatic Dermographism, Chronic Inducible Urticaria
- Trial name
- CHILL-MC (NCT07181369)
- Testing
- GTX-B001, Normal Saline
- Where
- 5 sites in Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Granular Therapeutics Limited
Primary Immunodeficiency
ASIS for GAMMAGARD in Primary Immunodeficiency
ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle).
- Trial name
- ASISinPI (NCT02123615)
- Testing
- Gadolinium For abdomen, Gadolinium For lower back, Efficacy of Gammagard subcutaneously at Week 12
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ASIS Corporation
Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody, Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder)
Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ART5803 following IVIG administration in healthy participants to investigate the potential interactions between ART5803 and IVIG
- Conditions
- Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody, Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder), Autoimmune Encephalitis
- Trial name
- NCT06753955
- Testing
- ART5803, Intravenous immunoglobulin (IVIG)
- Where
- Australia
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Arialys Therapeutics
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
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
Immune Thrombocytopenic Purpura (ITP)
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic…
- Trial name
- NCT03866577
- Testing
- Biological: M254, Intravenous immunoglobulin (IVIg)
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Momenta Pharmaceuticals, Inc.
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)
Healthy Volunteers
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous [SC] infusion)…
- Trial name
- NCT06935266
- Testing
- TAK-881, SC Investigational Needle Sets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Takeda
Rheumatoid Arthritis, Complication of Transplant
Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104
First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
- Trial name
- NCT02800811
- Testing
- FR104
- Where
- Belgium
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Healthy
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.
- Trial name
- NCT01081691
- Testing
- CNTO 5825
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.
Burn Shock
Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients
Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.
- Trial name
- NCT05134792
- Testing
- intravenous immunoglobulin
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cairo University