Clinical trials: MAB
Malaria
Trial to Evaluate CIS43LS in Healthy Adults
Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection.
- Trial name
- NCT04206332
- Testing
- VRC-MALMAB0100-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Diphtheria
Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects
This study will examine the use of a single infusion of S315 at different doses in healthy volunteers to help understand its safety and tolerability.
- Trial name
- S315 (NCT04075175)
- Testing
- S315, 0.9% Sodium Chloride (NaCl)
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- MassBiologics
Healthy Donors
Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)
The first objective of the project consists in the preclinical validation of new possible molecular targets associated with intratumoral T regulatory cells.
- Trial name
- Immuno-ab (NCT06842407)
- Where
- Italy
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Checkmab S.r.l.
Healthy Subjects
A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon
This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.
- Trial name
- NCT07788807
- Testing
- Adalimumab, Guselkumab, SDL-001
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Surmount Services, Inc.
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.
Healthy Participants, Atopic Dermatitis
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis.
- Trial name
- NCT06564389
- Testing
- PF-07832837
- Where
- 5 sites in United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Pfizer
Fever, Adverse Event Following Immunisation
Safety of RSV Preventive Monoclonal Antibody
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously…
- Trial name
- NCT07158814
- Testing
- Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- Where
- 6 sites in United States
- Volunteers
- 524 people, healthy volunteers welcome
- Sponsor
- Duke University
Prevention of HIV Infection, HIV Antibodies
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults
Background: Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses.
- Conditions
- Prevention of HIV Infection, HIV Antibodies, Monoclonal Antibody, Human, Neutralizing Antibody
- Trial name
- NCT02599896
- Testing
- VRC-HIVMAB080-00-AB (VRC01LS), VRC-HIVMAB060-00-AB (VRC01)
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55.
- Trial name
- NCT06943378
- Testing
- Monoclonal antibody JST-010
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Just-Evotec Biologics
Rabies Virus Infection
Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials
To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people
- Trial name
- NCT06548139
- Testing
- Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg, Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg, Rabies Human Immunoglobulin (HRIG)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Changchun BCHT Biotechnology Co.
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
Healthy
FCM Analysis GR in Steroid-Treatment Patients
Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in determination GR before the steroid treatment in clinical, especially in steroid resistant states, in order to design more efficient…
- Trial name
- NCT00600652
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Changhai Hospital
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
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
Influenza
Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses
The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.
- Trial name
- NCT01756950
- Testing
- 2 mg/kg CR8020, 5 mg/kg CR8020, 15 mg/kg CR8020
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Rheumatoid Arthritis, Juvenile
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis
The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).
- Trial name
- NCT00036374
- Testing
- Infliximab
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.