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A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects

Trial Profile

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Sep 2020

At a glance

  • Drugs CT-P59 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Sponsors Celltrion
  • Most Recent Events

    • 11 Sep 2020 Interim results published in the Celltrion media release
    • 17 Jul 2020 According to a Celltrion media release, this study will be conducted in collaboration with Chungnam National University Hospital. The trial's completion is expected by Q3 of 2020.
    • 17 Jul 2020 Status changed from planning to recruiting, according to a Celltrion media release.

Trial Overview

Purpose

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects.

Primary Endpoints

Primary safety outcome

description: Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs)
Proportion of patients with TEAEs of special interest (IRR hypersensitivity/anaphylactic reaction
time_frame: Day 14

Other Endpoints

To evaluate the safety of CT-P59

description: Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs)
Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction)
Incidence of ADA and NAbs to CT-P59 (positive or negative)
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 1. Pharmacokinetic (PK) parameter: Area under the serum concentration-time curve from time zero to infinity, calculated using the linear up and low down trapezoidal rule(AUC0-inf) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 2. PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 3. PK parameter: AUC from time zero to the last quantifiable concentration, calculated using the linear up and log down trapezoidal rule(AUC0-last) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 4. PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 5. PK parameter: Maximum observed serum concentration(Cmax) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 6. PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 7. PK parameter: Time to Cmax(Tmax) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 8. PK parameter: Terminal elimination half-life(t1/2) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 9. PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 10. PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 11. PK parameter: Total body clearance(CL) of CT-P59
time_frame: Up to 90 Days

To evaluate the Pharmacokinetic(PK) of CT-P59

description: 12. PK parameter: Volume of distribution during the terminal phase(Vz) of CT-P59
time_frame: Up to 90 Days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 32

  • Sex male & female
  • Age Group 19-55 years; adult

Patient Inclusion Criteria

Each subject must meet all of the following criteria to be randomized in this study: 1. Subject is a healthy male or female subject, aged between 19 to 55 years (both inclusive). Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration. 2. Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits. 3. Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive). 4. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions. 5. Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.

Patient Exclusion Criteria

Subject meeting any of the following criteria will be excluded from the study: 1. Subject has a medical history or current presence of disease including one or more of the following(s): 1. History of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the Investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug 2. History of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the Investigator 3. History of or any concomitant active malignancy 4. History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C 5. History of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required IV antibiotics) within 6 months before the study drug administration 6. History of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the Investigator or requires hospitalization 7. History of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period 2. Subject had a history of or concurrent use of medications including any prior therapy of following(s): 1. Prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration 2. Any vaccination within 4 weeks prior to the study drug administration 3. Treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics 4. Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

Trial Details

Identifiers

Identifier Owner
NCT04525079 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-003065-19 European Clinical Trials Database
CT-P59 1-1 -

Organisations

  • Sponsors Celltrion
  • Affiliations Celltrion

Trial Dates

  • Initiation Dates

    Planned : 01 Jul 2020

    Actual : 18 Jul 2020

  • Primary Completion Dates

    Planned : 31 Aug 2020

  • End Dates

    Planned : 30 Nov 2020

Other Details

  • Design double-blind; parallel; prospective; randomised; sequential
  • Phase of Trial Phase I
  • Location South Korea
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
CT-P59Primary Drug Parenteral
-

Cohort 1

Cohort 1 will receive a dose of CT-P59 or matching placebo
Drug: CT-P59 (CT-P59 will be administered)
Drug: Placebo (Placebo-matching CT-P59)

Cohort 2

Cohort 2 will receive a dose of CT-P59 or matching placebo
Drug: CT-P59 (CT-P59 will be administered)
Drug: Placebo (Placebo-matching CT-P59)

Cohort 3

Cohort 3 will receive a dose of CT-P59 or matching placebo
Drug: CT-P59 (CT-P59 will be administered)
Drug: Placebo (Placebo-matching CT-P59)

Cohort 4

Cohort 4 will receive a dose of CT-P59 or matching placebo
Drug: CT-P59 (CT-P59 will be administered)
Drug: Placebo (Placebo-matching CT-P59)

Results

Adverse events

Results from a phase I trial showed that CT-P59 demonstrated a reassuring safety profile in the trial. No significant drug-related adverse events were observed and importantly there were no adverse events from the maximum tolerated dose cohort [2] .

Publications

  1. Celltrion. Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Celltrion 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
JangHee Hong, Dr Chungnam National University Hospital South-Korea
JiWoong Lim
+82-32-850-5702
JiWoong.Lim@celltrion.com
show details
-
JooHee Lee
+82-32-850-5707
JooHee.Lee@celltrion.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Celltrion
-
-
Chungnam National University Hospital Daejeon South-Korea

Trial History

Event Date Event Type Comment
11 Sep 2020 Interim results Interim results published in the Celltrion media release Updated 15 Sep 2020
27 Aug 2020 Other trial event New source identified and integrated (ClinicalTrial.gov: NCT04525079) Updated 27 Aug 2020
17 Jul 2020 Other trial event According to a Celltrion media release, this study will be conducted in collaboration with Chungnam National University Hospital. The trial's completion is expected by Q3 of 2020. Updated 21 Jul 2020
17 Jul 2020 Status change - recruiting Status changed from planning to recruiting, according to a Celltrion media release. Updated 21 Jul 2020
17 Jul 2020 Other trial event According to a Celltrion media release, the company announced the launch of this study following subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). Updated 21 Jul 2020
03 Apr 2020 Other trial event According to a Celltrion media release, the this trial is expected to begin by July 2020. Updated 08 Apr 2020
26 Mar 2020 New trial record New trial record Updated 26 Mar 2020
23 Mar 2020 Other trial event According to a Celltrion media release, this trial is expected to begin in 3Q 2020. Updated 26 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Celltrion. Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate. Media-Rel 2020;.

    Media Release
  3. Celltrion. Celltrion Accelerates Development of COVID-19 Antiviral Treatment and Aims to Launch Rapid Self-testing Kit. Media-Rel 2020;.

    Media Release
  4. Celltrion. Celltrions COVID-19 Antiviral Treatment Enters the Next Phase of Development. Media-Rel 2020;.

    Media Release
  5. Celltrion. Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time. Media-Rel 2020;.

    Media Release
  6. Celltrion. Celltrion Launches Human Clinical Trial of Potential COVID-19 Antiviral Antibody Treatment Following Positive Pre-Clinical Results. Media-Rel 2020;.

    Media Release
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