Clinical trials: Monoclonal
Healthy
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
- Trial name
- NCT00612196
- Testing
- TB-402
- Where
- Denmark
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ThromboGenics
Healthy Volunteers
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate…
- Trial name
- NCT04820439
- Testing
- recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627), Perjeta ®
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Breast Neoplasm
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
- Trial name
- NCT03013881
- Testing
- UB-921, Herceptin
- Where
- Taiwan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- United BioPharma
COVID-19
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198
This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
- Trial name
- NCT04479644
- Testing
- BRII-198
- Where
- China
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Brii Biosciences Limited
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
Community-acquired Pneumonia, Bacterial Pneumonia
A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunct therapy with standard of care antibiotics.
- Trial name
- NCT05629741
- Testing
- CMTX-101
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Clarametyx Biosciences, Inc.
Primary Hyperlipidemia and Mixed Dyslipidemia
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
- Trial name
- FLOREY (NCT02189837)
- Testing
- Evolocumab, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Amgen
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 Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
- Trial name
- NCT07222254
- Testing
- AZD0292
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Similarity of Pharmacokinetics and Safety
Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection
To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects
- Trial name
- NCT05323981
- Testing
- HS627(210mg/7ml), HS627(420mg/14ml), Perjeta
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed…
- Trial name
- SPAN (NCT05291520)
- Testing
- VH3810109, rHuPH20
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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.
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Family Study of Lymphoproliferative Disorders
Blood and lymph node cancers can begin in either the lymphatic tissues (as in the case of lymphoma) or in the bone marrow (as with leukemia and myeloma), and they all are involved with the uncontrolled growth of white blood…
- Conditions
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Monoclonal B-Cell Lymphocytosis
- Trial name
- NCT00626496
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
Healthy Volunteers
A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics of the solution form of Complarate and Actemra® in healthy volunteers.
- Trial name
- NCT06488521
- Testing
- Complarate, Actemra®
- Where
- 3 sites in Russia
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Healthy
A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody
The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects.
- Trial name
- NCT06021574
- Testing
- VDJ001
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
To evaluate the safety and tolerability of a single IV dose of MEDI-557.
- Trial name
- NCT00578682
- Testing
- MEDI-557
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Endometrial Carcinoma, Cervix Carcinoma
GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab
The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial…
- Trial name
- GYNET (NCT04652076)
- Testing
- NP137, Pembrolizumab, Paclitaxel
- Where
- 15 sites in France
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- NETRIS Pharma
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