Evidence map›Paper›PMID 36537346›Full record

Trial reportPharmacology research & perspectives2023

Phase 1 study of safety, pharmacokinetics, and antiviral activity of SARS-CoV-2 neutralizing monoclonal antibody ABBV-47D11 in patients with COVID-19.

Mohamad Shebley, Stanley Wang, Izna Ali, Preethi Krishnan, Rakesh Tripathi, Joseph M Reardon, John Cafardi, Galia Rahav, Yoseph Caraco, Jihad Slim and 5 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase I
In one paragraph

Trial report in Pharmacology research & perspectives, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 2 countries.

Mohamad ShebleyAbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0002-0147-8933
Stanley WangAbbVie Inc., North Chicago, Illinois, USA.
Izna AliAbbVie Inc., North Chicago, Illinois, USA.
Preethi KrishnanAbbVie Inc., North Chicago, Illinois, USA.
Rakesh TripathiAbbVie Inc., North Chicago, Illinois, USA.
Joseph M ReardonPrisma Health Upstate, Greenville, South Carolina, USA.ORCID 0000-0002-1093-5518
John CafardiThe Christ Hospital, Cincinnati, Ohio, USA.
Galia RahavSheba Medical Center and Tel-Aviv University, Tel Hashomer, Israel.
Yoseph CaracoHadassah-Hebrew University Medical Center, Jerusalem, Israel.
Jihad SlimNYMC, Valhalla, New York, USA.
Fadi Al AkhrassPikeville Medical Center, Pikeville, Kentucky, USA.
Mengjia YuAbbVie Inc., North Chicago, Illinois, USA.
Yiran HuAbbVie Inc., North Chicago, Illinois, USA.
Rosa De Abreu FerreiraAbbVie Inc., North Chicago, Illinois, USA.
Negar N AlamiAbbVie Inc., North Chicago, Illinois, USA.
AbbVie (United States) · USChrist Hospital · USHadassah Medical Center · ILNew York Medical College · USPikeville Medical Center · USPrisma Health · USTel Aviv University · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ABBV-47D11 is a neutralizing monoclonal antibody that targets a mutationally conserved hydrophobic pocket distal to the ACE2 binding site of SARS-CoV-2. This first-in-human safety, pharmacokinetics, and antiviral pharmacodynamic assessment in patients with COVID-19 provide an initial evaluation of this antibody that may allow further development. This multicenter, randomized, double-blind, and placebo-controlled single ascending dose study of ABBV-47D11 (180, 600, or 2400 mg) as an intravenous infusion, was in hospitalized and non-hospitalized (confined) adults with mild to moderate COVID-19. Primary outcomes were grade 3 or higher study drug-related adverse events and infusion-related reactions. Secondary outcomes were pharmacokinetic parameters and concentration-time profiles to Day 29, immunogenicity (anti-drug antibodies), and antiviral activity (change in RT-PCR viral load) from baseline to Days 15 and 29. ABBV-47D11 single doses up to 2400 mg were safe and tolerated and no safety signals were identified. The pharmacokinetics of ABBV-47D11 were linear and showed dose-proportional increases in serum concentrations with ascending doses. 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.

Indexed as

COVID-19AdultAntibodies, MonoclonalAntibodies, NeutralizingAntiviral AgentsHumansSARS-CoV-2Antibodies, MonoclonalAntibodies, NeutralizingAntiviral AgentsABBV-47D11COVID-19first-in-human studymonoclonal antibodiesSARS-CoV-2

Identifiers

PMID36537346
PMCPMC9764278
OpenAlexW4312065513

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.