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

• ClinicalTrials.gov Identifier: NCT05017168
• Recruitment Status: Completed
• First Posted: August 23, 2021
• Last Update Posted: August 11, 2022
• Sponsor: Celltrion
• Information provided by (Responsible Party): Celltrion

Study Description

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-P63 in Healthy Subjects.

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2 Infection	Drug: CT-P63; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 11, 2021
• Actual Primary Completion Date: November 12, 2021
• Actual Study Completion Date: January 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. To evaluate immunogenicity of single ascending dose of CT-P63: [ Time Frame: Up to 90 Days ]
   Incidence of ADA and NAbs to CT-P63 (positive or negative)
2. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   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)
3. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose)
4. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   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)
5. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose)
6. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   PK parameter: Maximum observed serum concentration(Cmax)
7. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose)
8. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   PK parameter: Time to Cmax(Tmax)
9. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
   PK parameter: Terminal elimination half-life(t1/2)
10. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext)
11. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz)
12. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Total body clearance(CL)
13. To evaluate the Pharmacokinetic(PK) of CT-P63 [ Time Frame: Up to 90 Days ]
    PK parameter: Volume of distribution at steady state (Vss)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 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

Contacts and Locations

Locations

Poland

Biokinetica S.A

Józefów, Poland, 05-410

Sponsors and Collaborators

Celltrion

Investigators

• Principal Investigator: Monika Kiecana, Dr.; Biokinetica S.A.

More Information

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT05017168
• Other Study ID Numbers: CT-P63 1.1; 2021-003530-37 ( EudraCT Number )
• First Posted: August 23, 2021
• Last Update Posted: August 11, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases