Evidence map›Paper›PMID 32339447›Full record

Trial reportClinical and translational science2020

hIL-7-hyFc, A Long-Acting IL-7, Increased Absolute Lymphocyte Count in Healthy Subjects.

Sang Won Lee, Donghoon Choi, MinKyu Heo, Eui-Cheol Shin, Su-Hyung Park, So Jeong Kim, Yeon-Kyung Oh, Byung Ha Lee, Se Hwan Yang, Young Chul Sung and 1 more

Registry-linked trialOpen 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. It is linked to trial NCT02860715 (A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Healthy Volunteers), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT02860715 phase1completednot on this map

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Healthy Volunteers

TypeinterventionalSponsorGenexine, Inc.Ran2016 to 2018Enrolled30ConditionsHealthyArmsGX-I7, Placebo
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

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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

11 authors at 5 institutions in 2 countries.

Sang Won LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.
Donghoon ChoiNeoImmuneTech, Inc., Rockville, Maryland, USA.
MinKyu HeoGenexine, Inc., Seongnam-si, Gyeonggi-do, Korea.
Eui-Cheol ShinGraduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.
Su-Hyung ParkGraduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.
So Jeong KimBiomedical Science and Engineering Interdisciplinary Program, Korea Advanced Institute of Science and Technology, Daejeon, Korea.
Yeon-Kyung OhGenexine, Inc., Seongnam-si, Gyeonggi-do, Korea.
Byung Ha LeeNeoImmuneTech, Inc., Rockville, Maryland, USA.
Se Hwan YangNeoImmuneTech, Inc., Rockville, Maryland, USA.
Young Chul SungGenexine, Inc., Seongnam-si, Gyeonggi-do, Korea.
Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.
Genexine (South Korea) · KRKorea Advanced Institute of Science and Technology · KROncoImmune (United States) · USHanyang University Seoul Hospital · KRSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A low lymphocyte count puts immune-compromised patients at risk of mortality. hIL-7-hyFc is a homodimeric interleukin-7 (IL-7), a potent T-cell amplifier, fused to the hybridizing IgD/IgG4 immunoglobulin domain. We performed a randomized, double-blind, placebo-controlled, dose-escalation, phase I study to assess the pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles of hIL-7-hyFc administered s.c. and i.m. to healthy volunteers. Thirty subjects randomly received hIL-7-hyFc or its matching placebo in an 8:2 ratio at 20, 60 μg/kg s.c., or 60 μg/kg i.m. The hIL-7-hyFc was slowly absorbed and its terminal half-life was 63.26 hours after i.m. administration. The hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks. The hIL-7-hyFc was well-tolerated after a single s.c. and i.m. administration. Injection site reaction was the most common treatment-emergent adverse event, which resolved spontaneously without treatment. The hIL-7-hyFc can be developed into a beneficial treatment option for patients with compromised T-cell immunity. This trial was registered at www.clinicaltrials.gov as #NCT02860715.

Indexed as

AdultDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansInterleukin-7Lymphocyte CountLymphocytesMaleMiddle AgedPlacebosRecombinant Fusion ProteinsYoung AdultIL7 protein, humanInterleukin-7PlacebosRecombinant Fusion Proteins

Identifiers

PMID32339447
PMCPMC7719369
OpenAlexW3019669427

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.