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To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525079
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: CT-P59 Drug: Placebo Phase 1

Detailed Description:
CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD 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 pharmacokinetics of CT-P59 will be evaluated in healthy subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : July 18, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: 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

Experimental: 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

Experimental: 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

Experimental: 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




Primary Outcome Measures :
  1. Primary safety outcome [ Time Frame: Day 14 ]
    1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
    2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs)
    3. Proportion of patients with TEAEs of special interest (IRR hypersensitivity/anaphylactic reaction


Secondary Outcome Measures :
  1. To evaluate the safety of CT-P59 [ Time Frame: Up to 90 Days ]
    1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
    2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs)
    3. Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction)
    4. Incidence of ADA and NAbs to CT-P59 (positive or negative)

  2. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    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

  3. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    2. PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose) of CT-P59

  4. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    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

  5. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    4. PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose) of CT-P59

  6. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    5. PK parameter: Maximum observed serum concentration(Cmax) of CT-P59

  7. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    6. PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59

  8. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    7. PK parameter: Time to Cmax(Tmax) of CT-P59

  9. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    8. PK parameter: Terminal elimination half-life(t1/2) of CT-P59

  10. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    9. PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext) of CT-P59

  11. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    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

  12. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    11. PK parameter: Total body clearance(CL) of CT-P59

  13. To evaluate the Pharmacokinetic(PK) of CT-P59 [ Time Frame: Up to 90 Days ]
    12. PK parameter: Volume of distribution during the terminal phase(Vz) of CT-P59



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525079


Contacts
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Contact: JooHee Lee +82-32-850-5707 JooHee.Lee@celltrion.com
Contact: JiWoong Lim +82-32-850-5702 JiWoong.Lim@celltrion.com

Locations
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Korea, Republic of
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: JangHee Hong, Dr         
Sponsors and Collaborators
Celltrion
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04525079    
Other Study ID Numbers: CT-P59 1.1
2020-003065-19 ( EudraCT Number )
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No