PMID- 37370000
OWN - NLM
STAT- MEDLINE
DCOM- 20230704
LR  - 20230704
IS  - 1471-2334 (Electronic)
IS  - 1471-2334 (Linking)
VI  - 23
IP  - 1
DP  - 2023 Jun 27
TI  - Safety, tolerability, pharmacokinetics, and immunogenicity of JMB2002-an antibody 
      against COVID-19: a phase 1 clinical trial in healthy Chinese adults.
PG  - 437
LID - 10.1186/s12879-023-08341-6 [doi]
LID - 437
AB  - BACKGROUND: The emergence of Severe Acute Respiratory Syndrome Coronavirus 2 
      (SARS-CoV-2) and subsequent Coronavirus Disease 2019 (COVID-19) pandemic has 
      resulted in a significant global public health burden, leading to an urgent need 
      for effective therapeutic strategies. Monoclonal antibodies (mAbs) are a 
      potentially effective therapeutic option. We identified a potent antibody JMB2002 
      against the SARS-CoV-2 receptor binding domain. JMB2002 has demonstrated 
      therapeutic efficacy in a SARS-CoV-2 infected rhesus macaque model. METHODS: We 
      conducted a randomized, double-blind, phase 1 trial to evaluate the JMB2002's 
      safety, tolerability, pharmacokinetics, and immunogenicity in healthy Chinese 
      adults. Participants were randomly assigned to one of four cohorts with 
      sequential dose, administrated intravenously with JMB2002 or placebo, and 
      followed up for 85 +/- 5 days. RESULTS: 40 participants were recruited and 
      completed in the study. Eight (25.0%) participants experienced 13 treatment 
      emergent adverse events (TEAEs) that were drug-related. No serious adverse events 
      (SAEs), dose limiting events (DLTs), or adverse events of special interest 
      (AESIs), such as infusion related/allergic reactions, were observed, and no drop 
      out due to adverse events (AEs) occurred. There was no significant safety 
      difference observed between JMB2002 and the placebo, suggesting it was well 
      tolerated. The AUC(0-infinity), AUC(0 - t) of JMB2002 infusion increased 
      dose-dependently from 5 mg/kg to 50 mg/kg while there is also a linear trend 
      between doses and C(max). CONCLUSION: Therefore, JMB2002 was well tolerated after 
      administration of a single dose in the range of 5 mg/kg to 50 mg/kg in healthy 
      Chinese adults. TRIAL REGISTRATION: ChiCTR2100042150 at 
      https://www.chictr.org.cn/searchproj.aspx (14/01/2021).
CI  - (c) 2023. The Author(s).
FAU - Chen, Guiling
AU  - Chen G
AD  - Institute of Pharmacology and Toxicology, College of Pharmaceutical Sciences, 
      Zhejiang University, Hangzhou, China.
AD  - Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan 
      International Medical College, Hangzhou, China.
FAU - Zhang, Ying
AU  - Zhang Y
AD  - Shanghai Jemincare Pharmaceutical Co., Ltd., Shanghai, China.
FAU - Wu, Kaiqi
AU  - Wu K
AD  - Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan 
      International Medical College, Hangzhou, China.
FAU - Jin, Tinghan
AU  - Jin T
AD  - Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan 
      International Medical College, Hangzhou, China.
FAU - Peng, Conggao
AU  - Peng C
AD  - Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan 
      International Medical College, Hangzhou, China.
FAU - Jiang, Qi
AU  - Jiang Q
AD  - Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan 
      International Medical College, Hangzhou, China.
FAU - Tian, Wenjuan
AU  - Tian W
AD  - Shanghai Jemincare Pharmaceutical Co., Ltd., Shanghai, China.
FAU - Chen, Zhong
AU  - Chen Z
AD  - Institute of Pharmacology and Toxicology, College of Pharmaceutical Sciences, 
      Zhejiang University, Hangzhou, China. chenzhong@zju.edu.com.
FAU - Shen, Zhenwei
AU  - Shen Z
AD  - Zhejiang Shuren University, Hangzhou, China. shenlin7818@126.com.
FAU - Sheng, Guoping
AU  - Sheng G
AD  - Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan 
      International Medical College, Hangzhou, China. guoping.sheng@shulan.com.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230627
PL  - England
TA  - BMC Infect Dis
JT  - BMC infectious diseases
JID - 100968551
RN  - 0 (Antibodies, Viral)
RN  - 0 (JMB2002)
SB  - IM
MH  - Animals
MH  - Humans
MH  - Antibodies, Viral
MH  - *COVID-19
MH  - Double-Blind Method
MH  - East Asian People
MH  - Immunogenicity, Vaccine
MH  - Macaca mulatta
MH  - SARS-CoV-2
MH  - Healthy Volunteers
PMC - PMC10304326
OTO - NOTNLM
OT  - COVID-19
OT  - JMB2002
OT  - SARS-CoV-2
COIS- The authors declare no competing interests.
EDAT- 2023/06/28 01:06
MHDA- 2023/06/29 06:43
PMCR- 2023/06/27
CRDT- 2023/06/27 23:35
PHST- 2023/03/09 00:00 [received]
PHST- 2023/05/22 00:00 [accepted]
PHST- 2023/06/29 06:43 [medline]
PHST- 2023/06/28 01:06 [pubmed]
PHST- 2023/06/27 23:35 [entrez]
PHST- 2023/06/27 00:00 [pmc-release]
AID - 10.1186/s12879-023-08341-6 [pii]
AID - 8341 [pii]
AID - 10.1186/s12879-023-08341-6 [doi]
PST - epublish
SO  - BMC Infect Dis. 2023 Jun 27;23(1):437. doi: 10.1186/s12879-023-08341-6.