Evidence map›Paper›PMID 35869929›Full record

Trial reportClinical and translational science2022

First-in-human, randomized, double-blind, placebo-controlled, dose escalation trial of the anti-herpes simplex virus monoclonal antibody HDIT101 in healthy volunteers.

Antje Blank, Nicolas Hohmann, Marlen Dettmer, Anette Manka-Stuhlik, Gerd Mikus, Felicitas Stoll, Marlies Stützle-Schnetz, Daniel Thomas, Evelyn Exner, Beate Schmitt-Bormann and 6 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2022. 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. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  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.

Antje BlankDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0001-8743-5194
Nicolas HohmannNCT, National Center for Tumor Diseases, Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Marlen DettmerNCT, National Center for Tumor Diseases, Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Anette Manka-StuhlikNCT, National Center for Tumor Diseases, Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Gerd MikusDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Felicitas StollDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Marlies Stützle-SchnetzDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Daniel ThomasHeidelberg ImmunoTherapeutics GmbH, Heidelberg, Germany.
Evelyn ExnerHeidelberg ImmunoTherapeutics GmbH, Heidelberg, Germany.
Beate Schmitt-BormannMedical Consulting Services, Pfungstadt, Germany.
Torsten SchallerHeidelberg ImmunoTherapeutics GmbH, Heidelberg, Germany.
Rico LaageHeidelberg ImmunoTherapeutics GmbH, Heidelberg, Germany.
Oliver Schönborn-KellenbergerCogitars GmbH, Heidelberg, Germany.
Michaela ArndtHeidelberg ImmunoTherapeutics GmbH, Heidelberg, Germany.
Walter E HaefeliDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0003-0672-6876
Jürgen KraussNCT, National Center for Tumor Diseases, Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

HDIT101 is a first-in-class humanized monoclonal antibody recognizing a conserved epitope in glycoprotein B, a target present on the surface of herpes simplex virus 1 (HSV-1) and HSV-2 particles as well as on virus-infected cells. This was a first-in-human, single-center, double-blind, placebo-controlled trial in 24 healthy volunteers, randomized 3:1 (placebo:active) in each of the six dose levels with escalating doses up to 12,150 mg HDIT101. HDIT101 was administered intravenously, to study safety, pharmacokinetics (PKs), and immunogenicity. HDIT101 was well-tolerated in all recipients and no serious or severe adverse events, no infusion-related reactions, and no events suggestive of dose limiting off-target toxicity occurred. The mean serum exposure (area under the curve from zero to infinity [AUC

Indexed as

Antibodies, MonoclonalAntibodies, ViralDouble-Blind MethodEpitopesHealthy VolunteersHumansAntibodies, MonoclonalAntibodies, ViralEpitopes

Identifiers

PMID35869929
PMCPMC9579396

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.