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
Latest Information Update: 22 Nov 2021
At a glance
- Drugs Regdanvimab (Primary)
- Indications COVID 2019 infections
- Focus Adverse reactions; First in man
- Sponsors Celltrion
- 11 Nov 2021 Status changed from recruiting to completed.
- 23 Aug 2021 Results published in the Clinical Therapeutics
- 11 Sep 2020 Interim results published in the Celltrion media release
Most Recent Events
Trial Overview
Purpose
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.
Primary Endpoints
Preliminary Safety and Tolerability of CT-P59
description: 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.
time_frame: Up to Day 14 after the subject administered with the study drug (Day 1)
Other Endpoints
Additional Safety of CT-P59 Including Immunogenicity
description: 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.
time_frame: Up to 90 Days
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
description: 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.
time_frame: Up to 90 Days
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
description: Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose)
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax
description: Data contains Maximum observed serum concentration(Cmax) of CT-P59
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax/Dose
description: Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Tmax
description: Data indicates Time to Cmax(Tmax) of CT-P59
time_frame: Up to 90 Days
Pharmacokinetic (PK) Parameter: t1/2
description: Data contains Terminal half-life (t1/2) of CT-P59
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: %AUCext
description: Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: λz
description: Data contains Terminal elimination rate constant (λz) of CT-P59
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: CL
description: Data contains Total body clearance (CL) of CT-P59
time_frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Vz
description: Data contains Volume of distribution during the elimination phase (Vz) of CT-P59
time_frame: Up to Day 90 [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Subjects
- Subject Type volunteers
-
Number
Planned: 32
Actual: 32
- Sex male & female
- Age Group 19-55 years; adult
Patient 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.
Patient 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
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04525079 | ClinicalTrials.gov: US National Institutes of Health |
EudraCT2020-003065-19 | European Clinical Trials Database |
CT-P59 1-1 | - |
Organisations
- Sponsors Celltrion
- Affiliations Celltrion
Trial Dates
-
Initiation Dates
Planned : 01 Jul 2020
Actual : 18 Jul 2020
-
Primary Completion Dates
Planned : 31 Aug 2020
Actual : 07 Aug 2020
-
End Dates
Planned : 30 Nov 2020
Actual : 05 Nov 2020
Other Details
- Design double-blind; parallel; prospective; randomised; sequential
- Phase of Trial Phase I
- Location South Korea
- Focus Adverse reactions; First in man
Interventions
Drugs | Route | Formulation |
---|---|---|
RegdanvimabPrimary Drug | Intravenous | Infusion |
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)
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)
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)
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)
Results
Adverse events
Results from a phase I trial showed that regdanvimab demonstrated a reassuring safety profile in the trial. No significant drug-related adverse events were observed and importantly there were no adverse events from the maximum tolerated dose cohort [2] .
Publications
-
Celltrion. Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate. Media-Rel 2020;.
Media Release -
Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, et al. 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;.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
JangHee Hong, Dr | Chungnam National University Hospital | South-Korea |
JiWoong Lim
+82-32-850-5702
show details
JiWoong.Lim@celltrion.com |
Celltrion |
-
|
JooHee Lee
+82-32-850-5707
show details
JooHee.Lee@celltrion.com |
Celltrion |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
Celltrion |
-
|
-
|
Chungnam National University Hospital | Daejeon | South-Korea |
Trial History
Event Date | Event Type | Comment |
---|---|---|
22 Nov 2021 | Other trial event | Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 22 Nov 2021 |
11 Nov 2021 | Status change - completed | Status changed from recruiting to completed. Updated 22 Nov 2021 |
23 Aug 2021 | Results | Results published in the Clinical Therapeutics Updated 30 Sep 2021 |
11 Sep 2020 | Interim results | Interim results published in the Celltrion media release Updated 15 Sep 2020 |
27 Aug 2020 | Other trial event | New source identified and integrated (ClinicalTrial.gov: NCT04525079) Updated 27 Aug 2020 |
17 Jul 2020 | Other trial event | According to a Celltrion media release, this study will be conducted in collaboration with Chungnam National University Hospital. The trial's completion is expected by Q3 of 2020. Updated 21 Jul 2020 |
17 Jul 2020 | Status change - recruiting | Status changed from planning to recruiting, according to a Celltrion media release. Updated 21 Jul 2020 |
17 Jul 2020 | Other trial event | According to a Celltrion media release, the company announced the launch of this study following subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). Updated 21 Jul 2020 |
03 Apr 2020 | Other trial event | According to a Celltrion media release, the this trial is expected to begin by July 2020. Updated 08 Apr 2020 |
26 Mar 2020 | New trial record | New trial record Updated 26 Mar 2020 |
23 Mar 2020 | Other trial event | According to a Celltrion media release, this trial is expected to begin in 3Q 2020. Updated 26 Mar 2020 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Celltrion. Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate. Media-Rel 2020;.
Media Release -
Celltrion. Celltrion Accelerates Development of COVID-19 Antiviral Treatment and Aims to Launch Rapid Self-testing Kit. Media-Rel 2020;.
Media Release -
Celltrion. Celltrions COVID-19 Antiviral Treatment Enters the Next Phase of Development. Media-Rel 2020;.
Media Release -
Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, et al. 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;.
PubMed | CrossRef Fulltext -
Celltrion. Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time. Media-Rel 2020;.
Media Release -
Celltrion. Celltrion Launches Human Clinical Trial of Potential COVID-19 Antiviral Antibody Treatment Following Positive Pre-Clinical Results. Media-Rel 2020;.
Media Release
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