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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: CT-P59; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celltrion

Publications and helpful links

General Publications

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
• Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2020
• Primary Completion (Actual): August 7, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CT-P59 1.1; 2020-003065-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No