Evidence map›Paper›PMID 42846794›Full record

Trial reportOpen forum infectious diseases2026

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients With Complicated

Loren G Miller, Vance G Fowler, Jose M Miro, Juan Pablo Horcajada, Nicholas Lewin-Koh, Tom Chu, Sharon Rymut, Johnny Gutierrez, Carrie M Rosenberger, Wouter L W Hazenbos and 3 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Loren G MillerDivision of Infectious Diseases, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, and Harbor-UCLA Medical Center, Torrance, California, USA.ORCID https://orcid.org/0000-0003-0487-1711
Vance G FowlerDepartment of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Jose M MiroHospital Clinic-IDIBAPS, University of Barcelona, and Reial Academia de Medicina de Catalunya (RAMC), Barcelona, Spain.ORCID https://orcid.org/0000-0001-8057-7755
Juan Pablo HorcajadaDepartment of Infectious Diseases, Hospital del Mar, Barcelona, Spain.
Nicholas Lewin-KohDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.
Tom ChuDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.
Sharon RymutDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.
Johnny GutierrezDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.
Carrie M RosenbergerDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.
Wouter L W HazenbosDepartment of Target Discovery, Genmab, Utrecht, The Netherlands.
Sara GlicksteinDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.
Jessica A CouchDepartment of Early Development, ReCode Therapeutics, Menlo Park, California, USA.ORCID https://orcid.org/0009-0005-6605-1809
Melicent C PeckDepartment of Early Clinical Development, Genentech, Inc., South San Francisco, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Safe and effective therapies are needed for hospitalized patients with complicated Methods: In this phase 1b, randomized, double-blind, placebo-controlled study, 25 patients with methicillin-sensitive (MSSA, 68%) or -resistant (MRSA, 32%) complicated Results: Most patients (92%) experienced ≥1 treatment-emergent adverse event (TEAE), of which 44% were considered treatment-related. Grade ≥3 TEAEs and serious adverse events occurred in 72% and 56% of patients, respectively. The most common grade ≥3 TEAEs were infusion-related reactions (IRRs), pneumonia, anemia, and respiratory failure. Four patients (21%) receiving DSTA4637S discontinued study treatment due to treatment-related IRRs. Systemic exposure of DSTA4637S in patients increased approximately dose-proportionally from 15 to 100 mg/kg but was 30%-60% lower than previously observed in healthy volunteers. Conclusions: The safety profile of DSTA4637S, characterized by unpredictable IRRs, and its pharmacokinetic behavior in patients differed substantially from those observed in healthy volunteers, highlighting the critical importance of conducting early phase studies in the target patient population.

Indexed as

antibody–antibiotic conjugatebacteremiaclinical trialStaphylococcus aureus

Identifiers

PMID42846794
PMCPMC13643602

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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.