Clinical trials: Monoclonal
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.
Staphylococcal Sepsis
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.
- Trial name
- N003 (NCT00631800)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Healthy Volunteers
Clinical Trial to Evaluate Pharmacokinetics,Safety and Immunogenicity of Single Injection of CDP1 to Healthy Volunteers Compared to Erbitux
Background Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and mortality of colorectal cancer in our country are on the rise.
- Trial name
- NCT03881787
- Testing
- anti-EGFR monoclonal antibody, Cetuximab injection
- Where
- 2 sites in China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Dragonboat Biopharmaceutical Company Limited
Rheumatoid Arthritis
Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis
This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile…
- Trial name
- NCT00504595
- Testing
- ACZ885 (investigational)
- Where
- 4 sites in Russia, Spain and 2 more
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Novartis
Healthy
First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.
- Trial name
- NCT04994912
- Testing
- EI-001
- Where
- 2 sites in Australia, China
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Elixiron Immunotherapeutics (Hong Kong) Ltd.
Anthrax
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Primary: To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 To evaluate…
- Trial name
- NCT01202695
- Testing
- AVP-21D9
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Cytomegalovirus Infections
Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.
- Trial name
- NCT01594437
- Testing
- TCN-202
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Theraclone Sciences, Inc.
Healthy Volunteers
A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for dengue, a mosquito-borne viral disease with extensive global public health impact.
- Trial name
- NCT04273217
- Testing
- AV-1
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AbViro LLC
Healthy
Study of CM310 in Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
- Trial name
- NCT06161090
- Testing
- CM310
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects.
- Trial name
- NCT04445038
- Testing
- 610
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Lower Respiratory Tract Infection
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
- Trial name
- CHIMES (NCT05110261)
- Testing
- Nirsevimab
- Where
- 30 sites in China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Osteoporosis
Assessment of Anti-RANKL Antibody in Post-menopausal Women
This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous injection of a fully human monoclonal antibody of receptor…
- Trial name
- NCT03242512
- Testing
- TK006
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
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
Healthy Volunteers
A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants
The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.
- Trial name
- NCT05970718
- Testing
- REGN7544
- Where
- New Zealand
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Asthma
A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers
This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma.
- Trial name
- NCT00411814
- Testing
- GSK679586
- Where
- 2 sites in Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Absolute Bioavailability
Absolute Bioavailability of Reslizumab in Healthy Subjects
The primary objective of this study is to assess the absolute bioavailability of reslizumab following administration of a single subcutaneous (sc) dose to healthy non-Japanese participants
- Trial name
- NCT01990443
- Testing
- Reslizumab IV, Reslizumab SC
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Rabies (Healthy Volunteers)
A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
A Phase II, Single-Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody Injection in Healthy Subjects
- Trial name
- NCT07445815
- Testing
- Recombinant Human Rabies Virus Monoclonal Antibody Injection, Human Rabies Immunoglobulin (HRIG), Rabies Vaccine
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
Healthy
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers
The primary objective of the study is to evaluate the safety and tolerability of ascending doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.
- Trial name
- NCT04601844
- Testing
- Pozelimab, Cemdisiran
- Where
- Belgium
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
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.
Malaria, Falciparum
First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults
This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.
- Trial name
- NCT07646353
- Testing
- GSK4425689A SC, GSK4425689A IV
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline