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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: CT-P59
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each subject must meet all of the following criteria to be randomized in this study: 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. Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits. Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive). Subject is able to understand and to comply with protocol requirements, instructions, and restrictions. 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: Subject has a medical history or current presence of disease including one or more of the following(s): 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 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 History of or any concomitant active malignancy History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C 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 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 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 Subject had a history of or concurrent use of medications including any prior therapy of following(s): 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 Any vaccination within 4 weeks prior to the study drug administration 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 Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Cohort 1 will receive a dose of CT-P59 or matching placebo | Drug: CT-P59<br>* CT-P59 will be administered<br>Drug: Placebo<br>* Placebo-matching CT-P59<br>|
| Experimental: Cohort 2<br>Cohort 2 will receive a dose of CT-P59 or matching placebo | Drug: CT-P59<br>* CT-P59 will be administered<br>Drug: Placebo<br>* Placebo-matching CT-P59<br>|
| Experimental: Cohort 3<br>Cohort 3 will receive a dose of CT-P59 or matching placebo | Drug: CT-P59<br>* CT-P59 will be administered<br>Drug: Placebo<br>* Placebo-matching CT-P59<br>|
| Experimental: Cohort 4<br>Cohort 4 will receive a dose of CT-P59 or matching placebo | Drug: CT-P59<br>* CT-P59 will be administered<br>Drug: Placebo<br>* Placebo-matching CT-P59<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary Safety and Tolerability of CT-P59 | A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug. | Up to Day 14 after the subject administered with the study drug (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Safety of CT-P59 Including Immunogenicity | A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug. | Up to 90 Days | 
| Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59. | Up to 90 Days | 
| Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose) | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: Cmax | Data contains Maximum observed serum concentration(Cmax) of CT-P59 | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: Cmax/Dose | Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59 | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: Tmax | Data indicates Time to Cmax(Tmax) of CT-P59 | Up to 90 Days | 
| Pharmacokinetic (PK) Parameter: t1/2 | Data contains Terminal half-life (t1/2) of CT-P59 | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: %AUCext | Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59 | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: λz | Data contains Terminal elimination rate constant (λz) of CT-P59 | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: CL | Data contains Total body clearance (CL) of CT-P59 | Up to Day 90 | 
| Pharmacokinetic (PK) Parameter: Vz | Data contains Volume of distribution during the elimination phase (Vz) of CT-P59 | Up to Day 90 |