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
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.

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.

Completed
SARS-CoV-2 Infection

Drug: CT-P63

CT-P63 will be administered

Drug: Placebo

Placebo-matching CT-P63

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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Poland
Locations

Biokinetica S.A
Józefów, Poland

Monika Kiecana, Dr., Principal Investigator
Biokinetica S.A.

NCT Number
MeSH Terms
COVID-19