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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003065-19 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will receive a dose of CT-P59 or matching placebo |
|
| Cohort 2 | Experimental | Cohort 2 will receive a dose of CT-P59 or matching placebo |
|
| Cohort 3 | Experimental | Cohort 3 will receive a dose of CT-P59 or matching placebo |
|
| Cohort 4 | Experimental | Cohort 4 will receive a dose of CT-P59 or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P59 | Drug | CT-P59 will be administered |
|
| 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) |
| 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 |
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Inclusion Criteria:
Each subject must meet all of the following criteria to be randomized in this study:
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):
Subject had a history of or concurrent use of medications including any prior therapy of following(s):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34551869 | Derived | 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. | |
| 34473343 |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P59 10 mg/kg | Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| FG001 | CT-P59 20 mg/kg | Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| FG002 | CT-P59 40 mg/kg | Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| FG003 | CT-P59 80 mg/kg | Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| FG004 | Placebo | Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P59 10 mg/kg | Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| BG001 | CT-P59 20 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety set: All subjects who receive a full or partial dose of the study drugs | Posted | Count of Participants | Participants | Up to Day 14 after the subject administered with the study drug (Day 1) |
|
Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P59 10 mg/kg | Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiWoong Lim | Celltrion Inc | 82-32-850-5806 | jiwoong.lim@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2020 | Sep 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2020 | Sep 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000716788 | regdanvimab |
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| Placebo | Drug | Placebo-matching CT-P59 |
|
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 |
| 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. |
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
| BG002 | CT-P59 40 mg/kg | Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| BG003 | CT-P59 80 mg/kg | Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| BG004 | Placebo | Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
| OG002 | CT-P59 40 mg/kg | Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| OG003 | CT-P59 80 mg/kg | Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
| OG004 | Placebo | Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. |
|
|
| Secondary | 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. | Safety set: All subjects who receive a full or partial dose of the study drugs. | Posted | Count of Participants | Participants | Up to 90 Days |
|
|
|
| Secondary | 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. | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | hr*ng/mL | Up to 90 Days |
|
|
|
| Secondary | 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) | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | hr*ng/mL/mg | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: Cmax | Data contains Maximum observed serum concentration(Cmax) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | ng/mL | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: Cmax/Dose | Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | ng/mL/mg | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: Tmax | Data indicates Time to Cmax(Tmax) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Median | Full Range | hr | Up to 90 Days |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: t1/2 | Data contains Terminal half-life (t1/2) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | hr | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: %AUCext | Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | Percentage of AUC0-inf | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: λz | Data contains Terminal elimination rate constant (λz) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | 1/hr | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: CL | Data contains Total body clearance (CL) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | mL/hr | Up to Day 90 |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter: Vz | Data contains Volume of distribution during the elimination phase (Vz) of CT-P59 | Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result | Posted | Mean | Standard Deviation | mL | Up to Day 90 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | CT-P59 20 mg/kg | Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 0 | 6 | 1 | 6 | 4 | 6 |
| EG002 | CT-P59 40 mg/kg | Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | CT-P59 80 mg/kg | Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Placebo | Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 0 | 8 | 0 | 8 | 1 | 8 |
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| C-reactive protein increased | Investigations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| White blood cells urine positive | Investigations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) |
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| Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) |
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| Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59 |
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| Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last) |
|
| Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose) |
|