Evidence map›Paper›PMID 31664766›Full record

Trial reportClinical and translational science2020

A Double-Blind, Phase I, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BOS161721 in Healthy Subjects.

Azra Hussaini, Rajat Mukherjee, Dina M Berdieva, Christen Glogowski, Richard Mountfield, Peter T C Ho

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2020. 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
0.3field-weighted citation impact, top 40% 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, 15 citations in OpenAlex.

  1. Targeting T follicular helper cells for lifelong health.Nature reviews. Drug discovery · 2026
    Review
  2. Article
  3. Review
  4. Review
  5. Lung-resident lymphocytes and their roles in respiratory infections and chronic respiratory diseases.Chinese medical journal pulmonary and critical care medicine · 2024
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. 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

6 authors at 2 institutions in 1 country.

Azra HussainiPAREXEL International Corporation, Waltham, Massachusetts, USA.
Rajat MukherjeeCytel, Cambridge, Massachusetts, USA.
Dina M BerdievaBoston Pharmaceuticals, Cambridge, Massachusetts, USA.
Christen GlogowskiBoston Pharmaceuticals, Cambridge, Massachusetts, USA.
Richard MountfieldBoston Pharmaceuticals, Cambridge, Massachusetts, USA.
Peter T C HoBoston Pharmaceuticals, Cambridge, Massachusetts, USA.
Cytel (United States) · USPAREXEL International (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this study was to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BOS161721, a humanized immunoglobulin G1 triple mutation (M252Y/S254T/T256E) monoclonal antibody that inhibits interleukin-21 (IL-21) bioactivity. This randomized, single-center, double-blind, placebo-controlled study randomized healthy volunteers 3:1 to single ascending intravenous and subcutaneous doses of BOS161721 (range 1-240 mg) or placebo. BOS161721 and placebo groups had similar rates of adverse events, mostly mild; none led to study discontinuation. There were no clinically significant findings in physical examination, vital signs, or laboratory assessment. In the pooled BOS161721 population, four subjects (8.5%) tested antidrug antibody-positive predose, and seven (14.9%) postdose. Absolute CD4+ lymphocyte count remained normal throughout follow-up. BOS161721 administered subcutaneously was absorbed slowly, with a median time to maximum concentration (T

Indexed as

AdolescentAdultAntibodies, MonoclonalArea Under CurveBiological AvailabilityCD4 Lymphocyte CountCD4-Positive T-LymphocytesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHalf-LifeHealthy VolunteersHumansImmune ToleranceAntibodies, MonoclonalInterleukin-21InterleukinsSTAT3 protein, humanSTAT3 Transcription Factor

Identifiers

PMID31664766
PMCPMC7070801
OpenAlexW2982512368

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.