Evidence map›Paper›PMID 34346165›Full record

Trial reportJournal of cellular and molecular medicine2021

A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers.

Xinghe Wang, Long Liu, Lu Qi, Chunpu Lei, Pu Li, Yu Wang, Chen Liu, Haihong Bai, Chengquan Han, Yinjian Sun and 1 more

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

Trial report in Journal of cellular and molecular medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.4field-weighted citation impact, top 43% 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

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
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  3. Review
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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 2 institutions in 1 country.

Xinghe WangPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-4197-8545
Long LiuPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Lu QiPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chunpu LeiPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Pu LiPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yu WangPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chen LiuPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Haihong BaiPhase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chengquan HanBeijing Northland Biotech. Co., Ltd., Beijing, China.
Yinjian SunBeijing Northland Biotech. Co., Ltd., Beijing, China.
Jincan LiuBeijing Northland Biotech. Co., Ltd., Beijing, China.
Capital Medical University · CNSinovac Biotech · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study evaluated the safety, tolerability, pharmacokinetics (PK) and anti-drug antibody (ADA) of the recombinant human thymosin β4 (NL005) for single and multiple intravenous injections in healthy subjects. Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days. The cohorts received ascending doses of either 0.05, 0.25, 0.5, 2.0, 5.0, 12.5 or 25.0 μg/kg in the single-dose trial. A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days. The adverse events were mild to moderate in intensity. There were no dose-limiting toxicities or serious adverse events. The plasma concentration, maximum peak concentration (C

Indexed as

AdultChinaCohort StudiesDose-Response Relationship, DrugDrug Administration ScheduleFemaleHealthy VolunteersHumansMaleThymosinThymosin beta(4)ThymosinThymosin beta(4)adverse eventanti-drug antibodyintravenousmyocardial infarctionpharmacokineticsrecombinant human thymosin β4safetyterminal clearancetolerability

Identifiers

PMID34346165
PMCPMC8419156
OpenAlexW3192494239

What OpenQuestion holds

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LicenceCC BY
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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.