PMID- 34346827
OWN - NLM
STAT- MEDLINE
DCOM- 20210830
LR  - 20221207
IS  - 2222-1751 (Electronic)
IS  - 2222-1751 (Linking)
VI  - 10
IP  - 1
DP  - 2021 Dec
TI  - Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of 
      MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal 
      antibody.
PG  - 1638-1648
LID - 10.1080/22221751.2021.1960900 [doi]
AB  - MW33 is a fully humanized IgG1kappa monoclonal neutralizing antibody, and may be used 
      for the prevention and treatment of coronavirus disease 2019 (COVID-19). We 
      conducted a randomized, double-blind, placebo-controlled, single-dose, 
      dose-escalation Phase 1 study to evaluate the safety, tolerability, 
      pharmacokinetics (PK), and immunogenicity of MW33. Healthy adults aged 18-45 
      years were sequentially enrolled into the 4, 10, 20, 40, and 60 mg/kg dose groups 
      and infused with MW33 over 60 +/- 15 min and followed for 85 days. All 42 enrolled 
      participants completed the MW33 infusion, and 40 participants completed the 
      85-day follow-up period. 34 participants received a single infusion of 4 (n = 2), 
      10 (n = 8), 20 (n = 8), 40 (n = 8), and 60 mg/kg (n = 8) of MW33. 27 subjects in 
      the test groups experienced 78 adverse events (AEs) post-dose, with an incidence 
      of 79.4% (27/34). The most common AEs included abnormal laboratory test results, 
      vascular and lymphatic disorders, and infectious diseases. The severity of AEs 
      was mainly Grade 1 (92 AEs), and three Grade 2 and one Grade 4. The main PK 
      parameters, maximum concentration (C(max)), and area under the concentration-time 
      curve (AUC(0-t), and AUC(0-infinity)) in 34 subjects showed a linear kinetic 
      relationship in the range of 10-60 mg/kg. The plasma half-life was approximately 
      25 days. The positive rates of serum ADAs and antibody titres were low with no 
      evidence of an impact on safety or PK. In conclusion, MW33 was well-tolerated, 
      demonstrated linear PK, with a lower positive rate of serum ADAs and antibody 
      titres in healthy subjects.Trial registration: ClinicalTrials.gov identifier: 
      NCT04427501.Trial registration: ClinicalTrials.gov identifier: NCT04533048.Trial 
      registration: ClinicalTrials.gov identifier: NCT04627584.
FAU - Meng, Xianmin
AU  - Meng X
AUID- ORCID: 0000-0002-1747-7783
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Wang, Peipei
AU  - Wang P
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Xiong, Yanqing
AU  - Xiong Y
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Wu, Yijun
AU  - Wu Y
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Lin, Xiaoyan
AU  - Lin X
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Lu, Song
AU  - Lu S
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Li, Ruowan
AU  - Li R
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Zhao, Bei
AU  - Zhao B
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Liu, Jing
AU  - Liu J
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Zeng, Shaoqing
AU  - Zeng S
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Zeng, Liyan
AU  - Zeng L
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Wu, Yan
AU  - Wu Y
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Lu, Yan
AU  - Lu Y
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
FAU - Zhang, Jinchao
AU  - Zhang J
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Liu, Datao
AU  - Liu D
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Wang, Shuhai
AU  - Wang S
AD  - Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, People's Republic of China.
FAU - Lu, Hongzhou
AU  - Lu H
AUID- ORCID: 0000-0002-8308-5534
AD  - Shanghai Public Health Clinical Center, Fudan University, Shanghai, People's 
      Republic of China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04627584
SI  - ClinicalTrials.gov/NCT04427501
SI  - ClinicalTrials.gov/NCT04533048
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Emerg Microbes Infect
JT  - Emerging microbes & infections
JID - 101594885
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/*pharmacology/*therapeutic use
MH  - Antiviral Agents/*pharmacology/*therapeutic use
MH  - COVID-19/diagnosis/immunology/*virology
MH  - Data Analysis
MH  - Female
MH  - Humans
MH  - Male
MH  - SARS-CoV-2/*drug effects/immunology
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Young Adult
MH  - *COVID-19 Drug Treatment
PMC - PMC8382006
OTO - NOTNLM
OT  - COVID-19
OT  - MW33 injection
OT  - Phase 1 clinical trial
OT  - SARS-CoV-2
OT  - monoclonal antibody
OT  - pharmacokinetic characteristics
OT  - safety
COIS- No potential conflict of interest was reported by the author(s).
EDAT- 2021/08/05 06:00
MHDA- 2021/08/31 06:00
PMCR- 2021/08/18
CRDT- 2021/08/04 12:17
PHST- 2021/08/05 06:00 [pubmed]
PHST- 2021/08/31 06:00 [medline]
PHST- 2021/08/04 12:17 [entrez]
PHST- 2021/08/18 00:00 [pmc-release]
AID - 1960900 [pii]
AID - 10.1080/22221751.2021.1960900 [doi]
PST - ppublish
SO  - Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 
      10.1080/22221751.2021.1960900.