Clinical Therapeutics, volume 43, issue 10, pages 1706-1727

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection

J C Kim ¹

Young Ik Jang ¹

Jang Hong ²

Jin Myung Jung ²

Jae-Hyeong Park ²

Adrian Streinu-Cercel ³

Anca Streinu-Cercel ³

Oana Săndulescu ³

Sang-Joon Lee ⁴

Su Jin Kim ⁴

Na Young Jung ⁴

Seul-Gi Lee ⁴

J M Park ⁴

E S Kim ⁴

Da Bee Jeon ⁴

Yeo Jin Lee ⁴

Bum Soo Kim ⁴

YH Lee ⁴

Yeon Mee Kim ⁵

Hide authors affiliations Show authors affiliations: 5 affiliations

Division of Infectious Diseases, Department of Internal Medicine, Incheon Medical Center, Incheon, Republic of Korea. |

Clinical Trials Center Chungnam National University Hospital Daejeon Republic of Korea |

National Institute for Infectious Diseases Prof. Dr. Matei Balș, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. |

⁴

Celltrion Inc, Incheon, Republic of Korea. |

⁵

Division of Infectious Diseases, Chungnam National University School of Medicine, Daejeon, Republic of Korea. |

Publication type: Journal Article

Publication date: 2021-10-01

Elsevier

Journal: Clinical Therapeutics

Quartile SCImago

Quartile WOS

Impact factor: 3.2

ISSN: 01492918, 1879114X

DOI: 10.1016/j.clinthera.2021.08.009

Copy DOI

Pharmacology

Pharmacology (medical)

Abstract

Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or placebo. Primary objectives of both studies were safety and tolerability up to day 14 after infusion. Secondary end points included pharmacokinetic properties. Study 1.2 also measured virology and clinical efficacy.Thirty-two individuals were randomized to study 1.1 (6 per CT-P59 dose cohort and 8 in the placebo cohort). By day 14 after infusion, adverse events (AEs) were reported in 2 individuals receiving CT-P59 20 mg/kg (headache and elevated C-reactive protein levels) and 1 receiving CT-P59 40 mg/kg (pyrexia) (all Common Terminology Criteria for Adverse Events grade 1). In study 1.2, 18 patients were randomized (5 per dose cohort and 3 in the placebo cohort). Sixteen AEs were reported in 10 patients receiving CT-P59. No AEs in either study led to study discontinuation. Greater reductions in viral titers were reported with CT-P59 than placebo in those with maximum titers >105 copies/mL. Mean time to recovery was 3.39 versus 5.25 days.CT-P59 exhibited a promising safety profile in healthy individuals and patients with mild SARS-CoV-2 infection, with potential antiviral and clinical efficacy in patients with mild SARS-CoV-2 infection. ClinicalTrials.gov identifier: NCT04525079 (study 1.1) and NCT04593641 (study 1.2).

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Frontiers in Immunology	Frontiers in Immunology, 2, 5% Frontiers in Immunology 2 publications, 5%
Biomedicine and Pharmacotherapy	Biomedicine and Pharmacotherapy, 2, 5% Biomedicine and Pharmacotherapy 2 publications, 5%
International Journal of Infectious Diseases	International Journal of Infectious Diseases, 2, 5% International Journal of Infectious Diseases 2 publications, 5%
Infection and Chemotherapy	Infection and Chemotherapy, 2, 5% Infection and Chemotherapy 2 publications, 5%
Open Forum Infectious Diseases	Open Forum Infectious Diseases, 2, 5% Open Forum Infectious Diseases 2 publications, 5%
Life	Life, 1, 2.5% Life 1 publication, 2.5%
Russian Chemical Bulletin	Russian Chemical Bulletin, 1, 2.5% Russian Chemical Bulletin 1 publication, 2.5%
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Pediatric Infectious Disease Journal	Pediatric Infectious Disease Journal, 1, 2.5% Pediatric Infectious Disease Journal 1 publication, 2.5%
Frontiers in Microbiology	Frontiers in Microbiology, 1, 2.5% Frontiers in Microbiology 1 publication, 2.5%
Diagnostics	Diagnostics, 1, 2.5% Diagnostics 1 publication, 2.5%
Tropical Medicine and Infectious Disease	Tropical Medicine and Infectious Disease, 1, 2.5% Tropical Medicine and Infectious Disease 1 publication, 2.5%
Frontiers in Medicine	Frontiers in Medicine, 1, 2.5% Frontiers in Medicine 1 publication, 2.5%
Vaccines	Vaccines, 1, 2.5% Vaccines 1 publication, 2.5%
Drugs	Drugs, 1, 2.5% Drugs 1 publication, 2.5%
Infection	Infection, 1, 2.5% Infection 1 publication, 2.5%
Signal Transduction and Targeted Therapy	Signal Transduction and Targeted Therapy, 1, 2.5% Signal Transduction and Targeted Therapy 1 publication, 2.5%
Antiviral Research	Antiviral Research, 1, 2.5% Antiviral Research 1 publication, 2.5%
Current Therapeutic Research	Current Therapeutic Research, 1, 2.5% Current Therapeutic Research 1 publication, 2.5%
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Immunity	Immunity, 1, 2.5% Immunity 1 publication, 2.5%
The Lancet Infectious Diseases	The Lancet Infectious Diseases, 1, 2.5% The Lancet Infectious Diseases 1 publication, 2.5%
Cochrane Database of Systematic Reviews	Cochrane Database of Systematic Reviews, 1, 2.5% Cochrane Database of Systematic Reviews 1 publication, 2.5%
ACS Infectious Diseases	ACS Infectious Diseases, 1, 2.5% ACS Infectious Diseases 1 publication, 2.5%
Expert Opinion on Investigational Drugs	Expert Opinion on Investigational Drugs, 1, 2.5% Expert Opinion on Investigational Drugs 1 publication, 2.5%
BMJ Open	BMJ Open, 1, 2.5% BMJ Open 1 publication, 2.5%
BMC pharmacology & toxicology	BMC pharmacology & toxicology, 1, 2.5% BMC pharmacology & toxicology 1 publication, 2.5%
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Citations by publishers

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Elsevier	Elsevier, 10, 25% Elsevier 10 publications, 25%
Multidisciplinary Digital Publishing Institute (MDPI)	Multidisciplinary Digital Publishing Institute (MDPI), 7, 17.5% Multidisciplinary Digital Publishing Institute (MDPI) 7 publications, 17.5%
Springer Nature	Springer Nature, 5, 12.5% Springer Nature 5 publications, 12.5%
Frontiers Media S.A.	Frontiers Media S.A., 4, 10% Frontiers Media S.A. 4 publications, 10%
American College of Physicians	American College of Physicians, 2, 5% American College of Physicians 2 publications, 5%
Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, Korean Society for AIDS	Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, Korean Society for AIDS, 2, 5% Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, Korean Society for AIDS 2 publications, 5%
Oxford University Press	Oxford University Press, 2, 5% Oxford University Press 2 publications, 5%
Spandidos Publications	Spandidos Publications, 1, 2.5% Spandidos Publications 1 publication, 2.5%
Wolters Kluwer Health	Wolters Kluwer Health, 1, 2.5% Wolters Kluwer Health 1 publication, 2.5%
Wiley	Wiley, 1, 2.5% Wiley 1 publication, 2.5%
American Chemical Society (ACS)	American Chemical Society (ACS), 1, 2.5% American Chemical Society (ACS) 1 publication, 2.5%
Taylor & Francis	Taylor & Francis, 1, 2.5% Taylor & Francis 1 publication, 2.5%
Cold Spring Harbor Laboratory	Cold Spring Harbor Laboratory, 1, 2.5% Cold Spring Harbor Laboratory 1 publication, 2.5%
BMJ	BMJ, 1, 2.5% BMJ 1 publication, 2.5%
Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii	Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii, 1, 2.5% Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii 1 publication, 2.5%
	2 4 6 8 10

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Kim J. C. et al. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection // Clinical Therapeutics. 2021. Vol. 43. No. 10. pp. 1706-1727.

GOST all authors (up to 50) Copy

Kim J. C., Jang Y. I., Hong J., Jung J. M., Park J., Streinu-Cercel A., Streinu-Cercel A., Săndulescu O., Lee S., Kim S. J., Jung N. Y., Lee S., Park J. M., Kim E. S., Jeon D. B., Lee Y. J., Kim B. S., Lee Y., Kim Y. M. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection // Clinical Therapeutics. 2021. Vol. 43. No. 10. pp. 1706-1727.

RIS |

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RIS Copy

TY - JOUR

DO - 10.1016/j.clinthera.2021.08.009

UR - https://doi.org/10.1016/j.clinthera.2021.08.009

TI - Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection

T2 - Clinical Therapeutics

AU - Kim, J C

AU - Jang, Young Ik

AU - Hong, Jang

AU - Jung, Jin Myung

AU - Park, Jae-Hyeong

AU - Streinu-Cercel, Adrian

AU - Streinu-Cercel, Anca

AU - Săndulescu, Oana

AU - Lee, Sang-Joon

AU - Kim, Su Jin

AU - Jung, Na Young

AU - Lee, Seul-Gi

AU - Park, J M

AU - Kim, E S

AU - Jeon, Da Bee

AU - Lee, Yeo Jin

AU - Kim, Bum Soo

AU - Lee, YH

AU - Kim, Yeon Mee

PY - 2021

DA - 2021/10/01 00:00:00

PB - Elsevier

SP - 1706-1727

IS - 10

VL - 43

SN - 0149-2918

SN - 1879-114X

ER -

BibTex |

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BibTex Copy

@article{2021_Kim,

author = {J C Kim and Young Ik Jang and Jang Hong and Jin Myung Jung and Jae-Hyeong Park and Adrian Streinu-Cercel and Anca Streinu-Cercel and Oana Săndulescu and Sang-Joon Lee and Su Jin Kim and Na Young Jung and Seul-Gi Lee and J M Park and E S Kim and Da Bee Jeon and Yeo Jin Lee and Bum Soo Kim and YH Lee and Yeon Mee Kim},

title = {Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection},

journal = {Clinical Therapeutics},

year = {2021},

volume = {43},

publisher = {Elsevier},

month = {oct},

url = {https://doi.org/10.1016/j.clinthera.2021.08.009},

number = {10},

pages = {1706--1727},

doi = {10.1016/j.clinthera.2021.08.009}

}

MLA

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MLA Copy

Kim, J. C., et al. “Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection.” Clinical Therapeutics, vol. 43, no. 10, Oct. 2021, pp. 1706-1727. https://doi.org/10.1016/j.clinthera.2021.08.009.

Found error?

Publisher

Elsevier

Journal

Clinical Therapeutics

Quartile SCImago

Quartile WOS

Impact factor

3.2

ISSN

01492918 (Print)
1879114X (Electronic)