Clinical trials: MAB
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
Respiratory Syncytial Virus (RSV), Respiratory Infection Virus
THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness
RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in…
- Trial name
- THRIVE (NCT07578298)
- Testing
- Nirsevimab (RSV-specific monoclonal antibody)
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Influenza
Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza
The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy adult volunteers that have been inoculated with the influenza A virus
- Trial name
- NCT01719874
- Testing
- TCN-032
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Theraclone Sciences, Inc.
Breast Cancer
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in…
- Trial name
- NCT04905667
- Testing
- GB221, Herceptin
- Where
- China
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Genor Biopharma Co., Ltd.
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.
Episodic Migraine, Chronic Migraine
CGRP Inhibition, Autonomic Function, and Migraine
The purpose of this clinical study is to better understand the function of the autonomic nervous system in patients with migraine. We aim to understand whether the autonomic functions change depending on the migraine status (i.e.
- Trial name
- CGRP-1 (NCT04628429)
- Testing
- Erenumab, Galcanezumab, Fremanezumab
- Where
- Austria
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
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.
Contraception
An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital…
- Trial name
- NCT04731818
- Testing
- ZB-06
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- KBio Inc
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
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 Participants
An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab
The purpose of this study is to compare the pharmacokinetic (PK) exposures of a single subcutaneous (SC) dose of tozorakimab administered using AI or APFS in healthy participants.
- Trial name
- NCT06908577
- Testing
- Tozorakimab, Autoinjector (AI) Device, Accessorised Prefilled Syringe (APFS) Device
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Adalimumab
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the…
- Trial name
- NCT05909852
- Testing
- ABP 501-HCF, ABP 501-LCF
- Where
- 3 sites in United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Amgen
Malaria,Falciparum
Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F
This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or subcutaneously at escalating dose levels in healthy, malaria naïve, adults.
- Trial name
- TB31F (NCT04238689)
- Testing
- TB31F
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
COVID-19
Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19 in adult subjects (≥ 18 years of age).
- Trial name
- NCT05142527
- Testing
- ADM03820
- Volunteers
- healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Healthy Volunteers
A Safety and Pharmacokinetic Study of Complarate (Tocilizumab Biosimilar) and Actemra® in Healthy Volunteers
This is a randomized double-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of Complarate and Actemra® in healthy volunteers.
- Trial name
- NCT06481202
- Testing
- Complarate®, Actemra®
- Where
- 2 sites in Russia
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Healthy Adult Subjects
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when…
- Trial name
- NCT03794180
- Testing
- TJ003234
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- I-Mab Biopharma US Limited
Ebola Virus Disease
An Open Study of the Safety and Pharmacokinetics of a Drug for the Emergency Prevention of Ebola Virus Disease
Open-label safety, tolerability, pharmacokinetics and immunogenicity study in three dose escalation groups
- Trial name
- NCT04717830
- Testing
- Gamezumab
- Where
- Russia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth…
- Conditions
- Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
- Trial name
- NCT05110118
- Testing
- LY01008, Avastin
- Where
- China
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Shandong Boan Biotechnology Co., Ltd
Malaria,Falciparum
Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali
Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat…
- Trial name
- NCT06413108
- Testing
- TB31F, Normal saline
- Where
- Mali
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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.