Clinical trials: MAB
Healthy
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085.
- Trial name
- NCT02380287
- Testing
- humanized monoclonal antibody against human IL-17
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biocad
RSV
Stakeholder-Informed RSV Prevention Economic Model in Botswana
The goal of this mixed methods study is to engage stakeholders to develop a health economic model to estimate the costs, health benefits, and value of respiratory syncytial virus (RSV) prevention strategies.
- Trial name
- NCT07756528
- Where
- Botswana
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Psoriasis
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability, Immunogenicity, and Pharmacodynamics (PD) of GSK2800528 in Healthy Subjects.
GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases.
- Trial name
- NCT01899755
- Testing
- GSK2800528, solution for injection, Adalimumab, solution for injection
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Methamphetamine Abuse
Safety Study of Ch-mAb7F9 for Methamphetamine Abuse
The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and…
- Trial name
- NCT01603147
- Testing
- normal saline, ch-mAb7f9
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- InterveXion Therapeutics, LLC
Asthma
A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects
This is a study to compare PK of tezepelumab exposure in healthy subjects by using vial and syringe, APFS, and AI.
- Trial name
- PATH-BRIDGE (NCT03989544)
- Testing
- Tezepelumab
- Where
- Germany
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects
This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.
- Trial name
- NCT06171048
- Testing
- CM310
- Where
- China
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Mycobacterium Infections
Study of Mycobacterial Infections
This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections.
- Trial name
- NCT00018044
- Testing
- Clofazimine
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Therapeutic Treatment of Inhalation Anthrax
An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months ago will be enrolled and dosed as follows: A…
- Trial name
- NCT02016963
- Testing
- Raxibacumab
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
COVID-19
"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients".
A two-stage open-label, prospective, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity study with participation of healthy volunteers in three dose-escalation groups and patients with a confirmed…
- Trial name
- NCT07156864
- Testing
- 1/10 therapeutic dose, 1/2 therapeutic dose, full therapeutic dose
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Oropharyngeal Carcinoma
Anti-EGFR Therapy With IMRT Concurrent Chemoradiotherapy in Locally Advanced OPC Resistant to Induction Chemotherapy
This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with concurrent chemotherapy and anti-EGFR monoclonal antibody in locally advanced oropharyngeal carcinoma (OPC)…
- Trial name
- NCT04508829
- Testing
- Anti-EGFR monoclonal antibody
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Fudan University
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
Nasopharyngeal Carcinoma
Anti-EGFR Therapy Plus IMRT Concurrent Chemoradiotherapy in Locally Advanced NPC Resistant to Induction Chemotherapy
This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with concurrent chemotherapy and anti-EGFR monoclonal antibody in locally advanced nasopharyngeal carcinoma with…
- Trial name
- NCT04508816
- Testing
- cetuximab (CTX) or nimotuzumab (NTZ)
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Fudan University
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering…
- Trial name
- MEDI8897 Ph2b (NCT02878330)
- Testing
- MEDI8897
- Where
- 161 sites in United States, Argentina and 21 more
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
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.
Drug Safety
Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29
The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory response to various stimuli in humans and espacially during sepsis.
- Trial name
- NCT01319903
- Testing
- CaCP29, a humanized monoclonal antibody
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- InflaRx GmbH
Lyme Disease
First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People
This is a research study of the investigational drug 2217LS in healthy volunteers. Investigational means 2217LS is a new drug that has not been approved for the treatment of any disease.
- Trial name
- NCT04863287
- Testing
- 2217LS, 0.9% Sodium Chloride (NaCl)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- MassBiologics
Clostridium Tetanus
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation
- Trial name
- NCT06360250
- Testing
- Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Tetanus human immunoglobulin (HTIG), Adsorbed tetanus vaccine (TT)
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Changchun BCHT Biotechnology Co.
Healthy Subjects
Phase 1 Study of Intravaginal KB15A
The goal of this clinical trial is to determine the safety and mucosal pharmacokinetics of KB15A, a vaginal film containing an anti-sperm monoclonal antibody, in healthy adult women.
- Trial name
- NCT07222020
- Testing
- KB15A Vaginal Film
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ZabBio Inc.
HIV/AIDS
A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
- Trial name
- NCT03721510
- Testing
- PGT121 + VRC07-523LS, PGT121 + VRC07-523LS + PGDM1400
- Where
- 3 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Healthy Volunteer
A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.
- Trial name
- NCT05603195
- Testing
- REGN7508 (IV), REGN7508 (SC)
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals