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

NCT04525079 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CT-P59 1.12020-003065-19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Additional Safety of CT-P59 Including Immunogenicity

  Up to 90 Days

• Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last

  Up to 90 Days

• Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose

  Up to Day 90

• Pharmacokinetic (PK) Parameter: Cmax

  Up to Day 90

• Pharmacokinetic (PK) Parameter: Cmax/Dose

  Up to Day 90

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: CT-P59; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: CT-P59; Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: CT-P59; Drug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: CT-P59; Drug: Placebo

Interventions

CT-P59 DRUG

CT-P59 will be administered

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Placebo-matching CT-P59

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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):
• 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
• Any vaccination within 4 weeks prior to the study drug administration
• 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
• Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34551869 DERIVED

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

regdanvimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: JiWoong Lim
• Organization: Celltrion Inc

jiwoong.lim@celltrion.com

82-32-850-5806

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 25, 2020
• Study Start: July 18, 2020
• Primary Completion: August 7, 2020
• Study Completion: November 5, 2020
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-09

Locations

KR (1)