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

NCT05017168 | Completed Phase 1 DMC

• 2 other identifiers: CT-P63 1.12021-003530-37
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• To evaluate safety and tolerability of single ascending dose of CT-P63:

  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

  Up to 14 Days

Secondary Outcomes (13)

• To evaluate immunogenicity of single ascending dose of CT-P63:

  Up to 90 Days

• To evaluate the Pharmacokinetic(PK) of CT-P63

  Up to 90 Days

• To evaluate the Pharmacokinetic(PK) of CT-P63

  Up to 90 Days

• To evaluate the Pharmacokinetic(PK) of CT-P63

  Up to 90 Days

• To evaluate the Pharmacokinetic(PK) of CT-P63

  Up to 90 Days

Study Arms (2)

CT-P63

EXPERIMENTAL

Single Ascending Dose

Drug: CT-P63

Placebo

PLACEBO COMPARATOR

Single Ascending Dose

Drug: Placebo

Interventions

CT-P63 DRUG

CT-P63 will be administered

CT-P63

Placebo DRUG

Placebo-matching CT-P63

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Each subject must meet all of the following criteria to be randomized in this study:
• 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.
• Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
• Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.

You may not qualify if:

• A 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):
• 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
• 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
• History of malignancy within past 5 years or any current malignancy
• Current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C
• 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
• 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
• 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
• Subject had a history of or concurrent use of medications including any prior therapy of following(s):
• 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
• 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
• 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
• Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Biokinetica S.A

Józefów, 05-410, Poland

Location

MeSH Terms

Conditions

COVID-19

Interventions

CT-P63

Condition Hierarchy (Ancestors)

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

Study Officials

• Monika Kiecana, Dr.

  Biokinetica S.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 23, 2021
• Study Start: October 11, 2021
• Primary Completion: November 12, 2021
• Study Completion: January 25, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

PL (1)