RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers
NCT04700163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-03-13
Summary
This is a first-in-human, open label, single dose, dose-escalation phase 1 study to evaluate the safety and pharmacokinetics of a combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy volunteers.
Conditions
- Covid19
Interventions
- BIOLOGICAL
-
C144-LS and C-135-LS
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
Sponsors & Collaborators
-
Rockefeller University
lead OTHER
Principal Investigators
-
Christian Gaebler, MD · The Rockefeller University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-11
- Primary Completion
- 2022-02-02
- Completion
- 2022-02-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
NCT04368728 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
NCT04427501 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
NCT05997290 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects
NCT04780321 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of LY3832479 (LY-CoV016) in Healthy Participants
NCT04441931 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
NCT06113744 ·Status: RECRUITING ·Phase: PHASE1
-
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
NCT04426695 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
NCT04551898 ·Status: COMPLETED ·Phase: PHASE2
-
A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
NCT06878170 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
NCT04785144 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19
NCT05216601 ·Status: COMPLETED ·Phase: PHASE1
-
Tolerability,Safety,Pharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody (JS016) for Injection in Chinese Health Subjects
NCT04441918 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19
NCT04487210 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
NCT02114268 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants
NCT04860297 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)
NCT04283461 ·Status: COMPLETED ·Phase: PHASE1
-
Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Individuals
NCT05788185 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults
NCT05011526 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
NCT05477186 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
NCT04479631 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults
NCT04590430 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
NCT05505448 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)
NCT05007509 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
NCT04450004 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
NCT04713553 ·Status: COMPLETED ·Phase: PHASE3