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- || lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
PK/PD data, Journal: Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration. (Pubmed Central) - Dec 5, 2024
Combining inhalation with intravenous therapy results in high and sustained DZIF-10c exposure in the lungs and systemic circulation, thereby combining the benefits of both routes of administration. By combining preclinical data with clinical data (via allometric scaling principles), the developed population pharmacokinetic model reduced uncertainty around exposure in the lungs allowing evaluation of alternative dosing strategies to achieve the desired concentrations of DZIF-10c in human lungs.
- lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
Trial termination: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - Nov 18, 2021
P2/3, N=5, Terminated, Sponsor: Boehringer Ingelheim
By combining preclinical data with clinical data (via allometric scaling principles), the developed population pharmacokinetic model reduced uncertainty around exposure in the lungs allowing evaluation of alternative dosing strategies to achieve the desired concentrations of DZIF-10c in human lungs. Active, not recruiting --> Terminated; not due to safety reasons
- | DZIF-10c IV / Boehringer Ingelheim
Preclinical, Journal: Intranasal Administration of a Monoclonal Neutralizing Antibody Protects Mice against SARS-CoV-2 Infection. (Pubmed Central) - Sep 12, 2021
Along with a favorable pharmacokinetic profile, these results highlight DZIF-10c as a novel human SARS-CoV-2 neutralizing antibody with high in vitro and in vivo antiviral potency. The successful intranasal application of DZIF-10c paves the way for clinical trials investigating topical delivery of anti-SARS-CoV-2 antibodies.
- ||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim
Trial completion: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion (clinicaltrials.gov) - Aug 23, 2021
P1/2, N=57, Completed, Sponsor: University of Cologne
The successful intranasal application of DZIF-10c paves the way for clinical trials investigating topical delivery of anti-SARS-CoV-2 antibodies. Active, not recruiting --> Completed
- || lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
Enrollment change, Trial withdrawal: A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2 (clinicaltrials.gov) - Aug 18, 2021
P3, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed N=1700 --> 0 | Not yet recruiting --> Withdrawn
- ||||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
Enrollment change: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - Aug 18, 2021
P2/3, N=5, Active, not recruiting, Sponsor: Boehringer Ingelheim
N=1700 --> 0 | Not yet recruiting --> Withdrawn N=1500 --> 5
- lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
Enrollment closed: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - Aug 3, 2021
P2/3, N=5, Active, not recruiting, Sponsor: Boehringer Ingelheim
N=1500 --> 5 Terminated --> Active, not recruiting
- |||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
Trial primary completion date: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - Jun 2, 2021
P2/3, N=1500, Recruiting, Sponsor: Boehringer Ingelheim
Terminated --> Active, not recruiting Trial primary completion date: May 2021 --> May 2022
- |||||||||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
New P3 trial: A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2 (clinicaltrials.gov) - May 19, 2021
P3, N=1700, Not yet recruiting, Sponsor: Boehringer Ingelheim
- || lomtegovimab (BI 767551 IV) / Boehringer Ingelheim
Enrollment closed: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion (clinicaltrials.gov) - May 12, 2021
P1/2, N=57, Active, not recruiting, Sponsor: University of Cologne
Trial primary completion date: May 2021 --> May 2022 Recruiting --> Active, not recruiting
- |||||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
Enrollment open: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - Apr 22, 2021
P2/3, N=1440, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim, DZIF-10c inhalation / Boehringer Ingelheim
New P2/3 trial: A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - Mar 29, 2021
P2/3, N=1440, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim
Enrollment open: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion (clinicaltrials.gov) - Mar 21, 2021
P1/2, N=57, Recruiting, Sponsor: University of Cologne
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| lomtegovimab (BI 767551 IV) / Boehringer Ingelheim
New P1/2 trial: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion (clinicaltrials.gov) - Nov 17, 2020
P1/2, N=69, Not yet recruiting, Sponsor: University of Cologne