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

NCT ID: NCT04525079

Last Updated: 2021-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-18
• Study Completion Date: 2020-11-05

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.

Conditions

SARS-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

Cohort 1 will receive a dose of CT-P59 or matching placebo

Group Type: EXPERIMENTAL

CT-P59

Intervention Type: DRUG

CT-P59 will be administered

Placebo

Intervention Type: DRUG

Placebo-matching CT-P59

Cohort 2

Cohort 2 will receive a dose of CT-P59 or matching placebo

Group Type: EXPERIMENTAL

CT-P59

Intervention Type: DRUG

CT-P59 will be administered

Placebo

Intervention Type: DRUG

Placebo-matching CT-P59

Cohort 3

Cohort 3 will receive a dose of CT-P59 or matching placebo

Group Type: EXPERIMENTAL

CT-P59

Intervention Type: DRUG

CT-P59 will be administered

Placebo

Intervention Type: DRUG

Placebo-matching CT-P59

Cohort 4

Cohort 4 will receive a dose of CT-P59 or matching placebo

Group Type: EXPERIMENTAL

CT-P59

Intervention Type: DRUG

CT-P59 will be administered

Placebo

Intervention Type: DRUG

Placebo-matching CT-P59

Interventions

CT-P59

CT-P59 will be administered

Intervention Type: DRUG

Placebo

Placebo-matching CT-P59

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 34551869 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-003065-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P59 1.1

Identifier Type: -

Identifier Source: org_study_id