Evidence map›Paper›PMID 40673766›Full record

Trial reportAntimicrobial agents and chemotherapy2025

Safety, tolerability, and pharmacokinetics of anti-SARS-CoV-2 monoclonal antibody SA55 injection in healthy participants.

Yibo Zhou, Xing Meng, Jianhua Li, Gang Zeng, Jin Wang, Yunlong Cao, Chaoying Hu, Ronghua Jin

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2025. 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

8 authors.

Yibo Zhou *Phase I Clinical Research Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-6379-2285
Xing Meng *Clinical Research and Development Center Sinovac Biotech Co., Ltd., Beijing, China.
Jianhua Li *Zhejiang Key Laboratory of Public Health Detection and Pathogenesis Research, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Gang ZengClinical Research and Development Center Sinovac Biotech Co., Ltd., Beijing, China.
Jin WangPhase I Clinical Research Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Yunlong CaoBiomedical Pioneering Innovation Center (BIOPIC), Peking University, Beijing, China.ORCID 0000-0001-5918-1078
Chaoying HuPhase I Clinical Research Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-0116-4387
Ronghua JinPhase I Clinical Research Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-8496-172X

Funding

Sinovac Biotech Co., Ltd. 20230601
6 · The paper itself

Abstract

This study aimed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and serum neutralizing activity of a single dose of SA55 injection in healthy individuals. A randomized, controlled, double-blind trial was conducted with 40 healthy volunteers aged 18-65 years. Participants received a single intramuscular injection of the investigational product at four dose levels (150 mg, 300 mg, 600 mg, and 900 mg), with randomization stratified by dose cohort. Dose proportionality and linearity of PK parameters (AUC

Indexed as

Antibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralSARS-CoV-2AdolescentAdultAgedArea Under CurveCOVID-19COVID-19 Drug TreatmentDouble-Blind MethodFemaleHalf-LifeHealthy VolunteersHumansInjections, IntramuscularAntibodies, MonoclonalAntibodies, NeutralizingAntibodies, Viralmonoclonal antibodypharmacokineticsSA55 injectionSARS-CoV-2

Identifiers

PMID40673766
PMCPMC12326955

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.