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OpenTrials
Completed

NCT Number: NCT04593641

This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Incheon Medical Center

Incheon, South Korea

About this study

'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Each patient must meet all of the following criteria to be randomized in this study:

  • Adult male or female patient, aged between 18 to 60 years (both inclusive).
  • Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
  • Patient has mild conditions meeting all of the following criteria:
  • Oxygen saturation ≥ 94% on room air.
  • Not requiring supplemental oxygen.
  • Onset of symptom is no more than 7 days prior to the study drug administration.

Exclusion criteria

  • Patient with severe condition meeting one of the following:
  • Respiratory distress with respiratory rate ≥ 30 breaths/min.
  • Requires supplemental oxygen.
  • Experience shock.
  • Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
  • Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.

Treatment and study plan

CT-P59

Biological

administered

Primary outcomes

  1. Number of Patients With TEAEs

    Time frame: Up to Day 14

  2. Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Up to Day 14

  3. Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)

    Time frame: Up to Day 14

  4. Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)

    Time frame: Up to Day 14

Secondary outcomes

  1. The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)

    Time frame: At Day 28

  2. Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

    Time frame: Up to Day 28

  3. Area Under the Concentration-time Curve of Viral Titers for qPCR

    Time frame: Up to Day 28

  4. Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

    Time frame: Up to Day 28

  5. Number of Patients With Clinical Recovery

    Time frame: Up to Day 28

  6. Number of Patients Requiring Supplemental Oxygen

    Time frame: Up to Day 28

  7. Number of Patients With Intensive Care Unit Transfer

    Time frame: Up to Day 28

  8. Number of Mechanical Ventilation

    Time frame: Up to Day 28

  9. Number of Patients With All-cause Mortality

    Time frame: Up to Day 28

  10. Number of Patients With Hospital Admission

    Time frame: Up to Day 28

  11. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  12. Time to Cmax (Tmax) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  13. Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  14. Terminal Half-life (t1/2) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  15. Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  16. Terminal Elimination Rate Constant (λz) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  17. Total Body Clearance (CL) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

  18. Volume of Distribution During the Elimination Phase (Vz) of CT-P59

    Time frame: Up to Day 90

    The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 20, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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