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
Overview
- Phase
- Phase 1
- Intervention
- CT-P59
- Conditions
- SARS-CoV-2 Infection
- Sponsor
- Celltrion
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Preliminary Safety and Tolerability of CT-P59
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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):
Arms & Interventions
Cohort 1
Cohort 1 will receive a dose of CT-P59 or matching placebo
Intervention: CT-P59
Cohort 1
Cohort 1 will receive a dose of CT-P59 or matching placebo
Intervention: Placebo
Cohort 2
Cohort 2 will receive a dose of CT-P59 or matching placebo
Intervention: CT-P59
Cohort 2
Cohort 2 will receive a dose of CT-P59 or matching placebo
Intervention: Placebo
Cohort 3
Cohort 3 will receive a dose of CT-P59 or matching placebo
Intervention: CT-P59
Cohort 3
Cohort 3 will receive a dose of CT-P59 or matching placebo
Intervention: Placebo
Cohort 4
Cohort 4 will receive a dose of CT-P59 or matching placebo
Intervention: CT-P59
Cohort 4
Cohort 4 will receive a dose of CT-P59 or matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Preliminary Safety and Tolerability of CT-P59
Time Frame: Up to Day 14 after the subject administered with the study drug (Day 1)
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.
Secondary Outcomes
- Additional Safety of CT-P59 Including Immunogenicity(Up to 90 Days)
- Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose(Up to Day 90)
- Pharmacokinetic (PK) Parameter: Vz(Up to Day 90)
- Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last(Up to 90 Days)
- Pharmacokinetic (PK) Parameter: CL(Up to Day 90)
- Pharmacokinetic (PK) Parameter: %AUCext(Up to Day 90)
- Pharmacokinetic (PK) Parameter: Cmax(Up to Day 90)
- Pharmacokinetic (PK) Parameter: Cmax/Dose(Up to Day 90)
- Pharmacokinetic (PK) Parameter: Tmax(Up to 90 Days)
- Pharmacokinetic (PK) Parameter: t1/2(Up to Day 90)
- Pharmacokinetic (PK) Parameter: λz(Up to Day 90)