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To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 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: NCT05017168
Recruitment Status : Not yet recruiting
First Posted : August 23, 2021
Last Update Posted : August 23, 2021
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-P63 in Healthy Subjects.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: CT-P63 Drug: Placebo Phase 1

Detailed Description:
CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 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-P63 will be evaluated in healthy subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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-P63 in Healthy Subjects
Estimated Study Start Date : September 24, 2021
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
Experimental: CT-P63
Single Ascending Dose
Drug: CT-P63
CT-P63 will be administered

Placebo Comparator: Placebo
Single Ascending Dose
Drug: Placebo
Placebo-matching CT-P63




Primary Outcome Measures :
  1. To evaluate safety and tolerability of single ascending dose of CT-P63: [ Time Frame: Up to 90 Days ]
    1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0
    2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0
    3. Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) by CTCAE v5.0


Secondary Outcome Measures :
  1. To evaluate immunogenicity of single ascending dose of CT-P63: [ Time Frame: Up to 90 Days ]
    Incidence of ADA and NAbs to CT-P63 (positive or negative)

  2. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    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)

  3. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose)

  4. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Area under the serum concentration-time curve from time zero to the last quantifiable concentration, calculated using the linear up and log down trapezoidal rule(AUC0-last)

  5. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose)

  6. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Maximum observed serum concentration(Cmax)

  7. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose)

  8. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Time to Cmax(Tmax)

  9. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Terminal elimination half-life(t1/2)

  10. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext)

  11. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz)

  12. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Total body clearance(CL)

  13. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Volume of distribution at steady state (Vss)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 18 to 60 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 with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
  3. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.

[Exclusion Criteria]

A 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 malignancy within past 5 years or any current malignancy
    4. 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. Any vaccination within 4 weeks prior to the study drug administration. For SARS-CoV-2 vaccine, subject who received any investigational or approved SARS-CoV-2 vaccine cannot be enrolled, regardless of the timing of administration
    2. 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
    3. 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
    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): NCT05017168


Contacts
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Contact: Jun Jung Kim +82 32 850 5734 junjung.kim@celltrion.com

Locations
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Poland
Biokinetica S.A
Józefów, Poland, 05-410
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: Monika Kiecana, Dr. Biokinetica S.A.
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT05017168    
Other Study ID Numbers: CT-P63 1.1
2021-003530-37 ( EudraCT Number )
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases