- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie
Clinical, P1 data, PK/PD data, Journal: Phase 1 study of safety, pharmacokinetics, and antiviral activity of SARS-CoV-2 neutralizing monoclonal antibody ABBV-47D11 in patients with COVID-19. (Pubmed Central) - Dec 21, 2022
The exploratory anti-SARS-CoV-2 activity revealed a reduction of viral load at and above the 600 mg dose of ABBV-47D11 regardless of patient demographics and baseline characteristics, however; because of the high inter-individual variability and small sample size a statistical significance was not reached. There is potential for anti-SARS-CoV-2 activity with ABBV-47D11 doses of 600 mg or higher, which could be evaluated in future clinical trials designed and powered to assess viral load reductions and clinical benefit.
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Trial completion, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Sep 2, 2021
P1, N=25, Completed,
There is potential for anti-SARS-CoV-2 activity with ABBV-47D11 doses of 600 mg or higher, which could be evaluated in future clinical trials designed and powered to assess viral load reductions and clinical benefit. Active, not recruiting --> Completed
- |||||||||| Preclinical, Journal: In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains. (Pubmed Central) - Aug 12, 2021
When administered after infection as therapy, higher doses of several mAb cocktails protected in vivo against viruses with a B.1.351 spike gene. Thus, many, but not all, of the antibody products with Emergency Use Authorization (EUA) should retain substantial efficacy against the prevailing SARS-CoV-2 variant strains.
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Enrollment closed, Enrollment change, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - May 19, 2021
P1, N=24, Active, not recruiting,
Thus, many, but not all, of the antibody products with Emergency Use Authorization (EUA) should retain substantial efficacy against the prevailing SARS-CoV-2 variant strains. Recruiting --> Active, not recruiting | N=54 --> 24
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Enrollment change, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Mar 15, 2021
P1, N=54, Recruiting,
Recruiting --> Active, not recruiting | N=54 --> 24 N=24 --> 54
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Enrollment open, Enrollment change, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Dec 17, 2020
P1, N=32, Recruiting,
N=24 --> 54 Not yet recruiting --> Recruiting | N=24 --> 32
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
New P1 trial, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Nov 24, 2020
P1, N=24, Not yet recruiting,
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