A Phase 1 study to evaluate the Safety, Tolerability and Pharmacokinetics of CT P59 in Healthy Subjects

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0005673
• Lead Sponsor: Celltrion

Brief Summary

This study was the first-in human study of CT-P59. It was a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects. Single IV infusion over 90 minutes (±15 minutes) of CT-P59 in doses of 10 mg/kg, 20 mg/kg, 40 mg/kg and 80 mg/kg was safe and well-tolerated in healthy subjects and no new major safety concerns were identified. Based on the pharmacokinetic analysis, CT-P59 was approximately dose proportional in terms of maximal and systemic exposure over the studied dose range of 10 mg/kg to 80 mg/kg and these active moieties will be largely out of the systemic circulation after 5 half-lives, i.e. approximately 95 days after administration.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-05
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits
• Subject with a body weight of = 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
• Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.

Exclusion Criteria

• 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 or any concomitant active malignancy
• History of or 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the preliminary safety and tolerability of CT-P59

Secondary Outcome Measures

Name	Time	Method
To evaluate the PK;To evaluate additional safety including immunogenicity