Evidence map›Paper›PMID 37817426›Full record

Trial reportClinical and translational science2023

MIJ821 (onfasprodil) in healthy volunteers: First-in-human, randomized, placebo-controlled study (single ascending dose and repeated intravenous dose).

Baltazar Gomez-Mancilla, Jeffrey A Levy, Subramanian Ganesan, Thomas Faller, Gil Issachar, Ziv Peremen, Offir Laufer, Revital Shani-Hershkovich, Kostas Biliouris, Ela Walker and 6 more

Abstract readRandomized Controlled Trial
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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Advancing past ketamine: emerging glutamatergic compounds for the treatment of depression.European archives of psychiatry and clinical neuroscience · 2025
    Review
  7. Review
  8. Review
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

16 authors.

Baltazar Gomez-MancillaNovartis Institutes for BioMedical Research, Novartis Pharma AG, Basel, Switzerland.
Jeffrey A LevySeaview A Quotient, Miami, Florida, USA.
Subramanian GanesanNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Thomas FallerNovartis Institutes for BioMedical Research, Novartis Pharma AG, Basel, Switzerland.
Gil IssacharElminda Ltd., Herzliya, Israel.
Ziv PeremenElminda Ltd., Herzliya, Israel.
Offir LauferElminda Ltd., Herzliya, Israel.
Revital Shani-HershkovichElminda Ltd., Herzliya, Israel.
Kostas BiliourisNovartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
Ela WalkerNovartis Institutes for BioMedical Research, Novartis Pharma AG, Basel, Switzerland.
Mark P HealyNovartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.ORCID 0000-0002-2541-5347
Oleksandr SverdlovNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.ORCID 0000-0002-1626-2588
Sachin DesaiNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.ORCID 0009-0007-6949-1521
S Nassir GhaemiNovartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
Jang-Ho ChaNovartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
Y Gopi ShankerNovartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This single-center study administered MIJ821 (onfasprodil) as an intravenous infusion to healthy volunteers and included two parts: a single ascending dose study (Part 1) and a repeated intravenous dose study (Part 2). Primary objective was to evaluate the safety and tolerability of single ascending intravenous doses infused over a 40-min period and of two repeated doses (1 week apart) of MIJ821 in healthy volunteers. Secondary objectives were to assess the pharmacokinetics of MIJ821 after intravenous infusion in Part 1 and Part 2 of the study. Overall, 43 subjects in Part 1 and 12 subjects in Part 2 were randomized in the study. Median age in Part 1 and Part 2 was 45.0 and 43.5 years, respectively, with the majority being Caucasian (Part 1: 84%; Part 2: 92%). 19 subjects (44.2%) in Part 1 and 8 subjects (66.7%) in Part 2 experienced at least one adverse event (AE). Following single dose in Part 1 and Part 2, the AUC

Indexed as

Infusions, IntravenousArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumans

Identifiers

PMID37817426
PMCPMC10651655

What OpenQuestion holds

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Registered trials

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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.