To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 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-P63 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-P63 in Healthy Subjects.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: CT-P63; Drug: Placebo

Detailed Description

CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 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-P63 will be evaluated in healthy subjects.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Józefów, Poland, 05-410
    • Biokinetica S.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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 18 to 60 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 with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
3. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.

[Exclusion Criteria]

A 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 malignancy within past 5 years or any current malignancy
   4. 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. Any vaccination within 4 weeks prior to the study drug administration. For SARS-CoV-2 vaccine, subject who received any investigational or approved SARS-CoV-2 vaccine cannot be enrolled, regardless of the timing of administration
   2. 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
   3. 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
   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: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-P63; Single Ascending Dose	Drug: CT-P63; CT-P63 will be administered
Placebo Comparator: Placebo; Single Ascending Dose	Drug: Placebo; Placebo-matching CT-P63

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate safety and tolerability of single ascending dose of CT-P63:	Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0; Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0; Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) by CTCAE v5.0	Up to 14 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate immunogenicity of single ascending dose of CT-P63:	Incidence of ADA and NAbs to CT-P63 (positive or negative)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	Pharmacokinetic (PK) parameter: Area under the serum concentration-time curve from time zero to infinity, calculated using the linear up and low down trapezoidal rule(AUC0-inf)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Area under the serum concentration-time curve from time zero to the last quantifiable concentration, calculated using the linear up and log down trapezoidal rule(AUC0-last)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Maximum observed serum concentration(Cmax)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Time to Cmax(Tmax)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Terminal elimination half-life(t1/2)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Total body clearance(CL)	Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Volume of distribution at steady state (Vss)	Up to 90 Days

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Principal Investigator: Monika Kiecana, Dr., Biokinetica S.A.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

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-P63 1.1; 2021-003530-37 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No