Evidence map›Paper›PMID 39058022›Full record

Trial reportAntimicrobial agents and chemotherapy2024

First-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending doses clinical study to assess the safety, tolerability, and pharmacokinetics of cipargamin administered intravenously in healthy adults.

Vinay Kumar Venishetty, Jean Lecot, Amanda Nguyen, Jie Zhang, William T Prince

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04321252 (A Randomized, Subject and Investigator-blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of KAE609 Administered Intravenously in Healthy Subjects), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04321252 phase1completednot on this map

A Randomized, Subject and Investigator-blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of KAE609 Administered Intravenously in Healthy Subjects

TypeinterventionalSponsorNovartis PharmaceuticalsRan2020 to 2020Enrolled57ConditionsMalariaArmsKAE609, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

5 authors.

Vinay Kumar VenishettyBioMedical Research, Novartis, Hyderabad, India.
Jean LecotNovartis Pharma AG, Basel, Switzerland.
Amanda NguyenBioMedical Research, Novartis, Cambridge, Massachusetts, USA.
Jie ZhangNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
William T PrinceBioMedical Research, Novartis, Cambridge, Massachusetts, USA.ORCID 0009-0000-5341-6382

Funding

Novartis (Novartis AG) NA
6 · The paper itself

Abstract

This first-in-human study assessed safety, tolerability, and pharmacokinetics (PK) of cipargamin (intravenous) in healthy adults. It included part 1, single ascending dose [SAD: 10.5 mg-210 mg; CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT04321252.

Indexed as

Administration, IntravenousAdultAntimalarialsArea Under CurveDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedYoung AdultAntimalarialscipargaminfirst-in-humanintravenousmalariapharmacokineticsafety

Identifiers

PMID39058022
PMCPMC11373227

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.