Evidence map›Paper›PMID 36661084›Full record

Trial reportClinical and translational science2023

First-in-human study with SAR445088: A novel selective classical complement pathway inhibitor.

Timothy Chow, Pirouz Shamszad, Christopher Vinnard, Esther Yoon, Julia Belinski, Irene Karpenko, Laurent Perrin, Kristen Auwarter, Michael Storek, Howard Surks and 2 more

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

Trial report in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

10 citing papers in PubMed, 19 citations in OpenAlex.

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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

12 authors at 3 institutions in 3 countries.

Timothy ChowSanofi, Cambridge, Massachusetts, USA.
Pirouz ShamszadSanofi, Bridgewater, New Jersey, USA.
Christopher VinnardSanofi, Bridgewater, New Jersey, USA.
Esther YoonParexel, Glendale, California, USA.
Julia BelinskiSanofi, Bridgewater, New Jersey, USA.
Irene KarpenkoSanofi, Bridgewater, New Jersey, USA.
Laurent PerrinSanofi, Montpellier, France.
Kristen AuwarterSanofi, Cambridge, Massachusetts, USA.
Michael StorekSanofi, Cambridge, Massachusetts, USA.
Howard SurksSanofi, Bridgewater, New Jersey, USA.
Nancy WongSanofi, Cambridge, Massachusetts, USA.
Yehuda Z CohenSanofi, Bridgewater, New Jersey, USA.ORCID 0000-0001-6987-1478
Sanofi (United States) · USPAREXEL International (United Kingdom) · GBSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

SAR445088 is an anti-C1s humanized monoclonal antibody that inhibits activated C1s in the proximal portion of the classical complement system and has the potential to provide clinical benefit in the treatment of complement-mediated diseases. A phase I, first-in-human, double-blind, randomized, placebo-controlled, dose-escalation trial of single and multiple doses of SAR445088 was conducted in 93 healthy participants to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles. Single (intravenous [i.v.] and subcutaneous [s.c.]) ascending doses (SAD) and multiple (s.c.) ascending doses (MAD) of SAR445088 were well-tolerated. The PK of SAR445088 was characterized by slow absorption after the s.c. dose and a long half-life (mean terminal half-life [t

Indexed as

Antibodies, Monoclonal, HumanizedComplement Pathway, ClassicalAdministration, IntravenousDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansAntibodies, Monoclonal, Humanized

Identifiers

PMID36661084
PMCPMC10087070
OpenAlexW4317532114

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.