Clinical trials: MAB
SARS-CoV-2 Infection
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation
This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals.
- Trial name
- NCT04631705
- Testing
- DZIF-10c
- Where
- 6 sites in Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Cologne
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)
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
HIV, Sexually Transmitted Infections (STI)
Monoclonal Antibody-based Multipurpose Microbicides
The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.
- Trial name
- Project WIND (NCT01859195)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion…
- Trial name
- NCT03928821
- Testing
- PGT121, PGDM1400, 10-1074
- Where
- 4 sites in United States
- Volunteers
- 27 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
MAB, Pain
Opioid Analgesia for MAB
Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing…
- Trial name
- NCT03139240
- Testing
- Oxycodone 10mg oral
- Where
- United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Healthy
A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects
To evaluate the safety and tolerability of raxibacumab in healthy subjects.
- Trial name
- NCT00639678
- Testing
- raxibacumab
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
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)
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)
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
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
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Kenyan Children
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective…
- Trial name
- NCT05400655
- Testing
- L9LS
- Where
- Kenya
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Inhalational Anthrax
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
- Trial name
- NCT01932437
- Testing
- ETI-204
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
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)
HIV Infections
Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected…
- Trial name
- NCT03387150
- Testing
- VRC07-523LS
- Where
- 7 sites in United States, Switzerland
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Respiratory Syncytial Virus
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm…
- Trial name
- MEDI8897 1b (NCT02290340)
- Testing
- MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
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
Endometrial Carcinoma
Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer
The purpose of this study is to find out whether the addition of a drug called Avastin (avastin) to the two-drug combination of carboplatin and paclitaxel shrinks tumors better than the two-drug combination alone in the treatment…
- Trial name
- NCT00879359
- Testing
- carboplatin, paclitaxel, and bevacizumab
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic