To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Intervention: CT-P59; Placebo
Intervention description: CT-P59 will be administered; Placebo-matching CT-P59
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: No

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.
    

Eligibility 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