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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017168
• Other study ID #: CT-P63 1.1
• Secondary ID: 2021-003530-37
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: August 2022
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 25, 2022
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

[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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• CT-P63
CT-P63 will be administered
• Placebo
Placebo-matching CT-P63

Locations

Country	Name	City	State
Poland	Biokinetica S.A	Józefów

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Maximum observed serum concentration(Cmax)	Up to 90 Days
Secondary	To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose)	Up to 90 Days
Secondary	To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Time to Cmax(Tmax)	Up to 90 Days
Secondary	To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Terminal elimination half-life(t1/2)	Up to 90 Days
Secondary	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
Secondary	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(?z)	Up to 90 Days
Secondary	To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Total body clearance(CL)	Up to 90 Days
Secondary	To evaluate the Pharmacokinetic(PK) of CT-P63	PK parameter: Volume of distribution at steady state (Vss)	Up to 90 Days