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Phase 1 N=32 Randomized Quadruple-blind Screening

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects

SARS-CoV-2 Infection

Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Nov 2021
Primary outcome: Primary: Preliminary Safety and Tolerability of CT-P59 — 0; 2; 1; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
CT-P59 (Drug); Placebo (Drug)
Age
Adult · 19+ yrs
Sex
All
Sponsor
Celltrion
Primary completion
Aug 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Preliminary Safety and Tolerability of CT-P59
0; 2; 1; 0; 1; 0
SECONDARY
Additional Safety of CT-P59 Including Immunogenicity
0; 4; 3; 0; 1; 0
SECONDARY
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
52469185.0; 88353384.1; 167086786.9; 335692549.3; 49593090.2; 86246911.1
SECONDARY
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
68774.1; 70620.6; 54763.5; 58981.8; 65200.8; 68847.6
SECONDARY
Pharmacokinetic (PK) Parameter: Cmax
233166.7; 406333.3; 1020000.0; 1941666.7
SECONDARY
Pharmacokinetic (PK) Parameter: Cmax/Dose
307.1; 321.5; 337.0; 342.0
SECONDARY
Pharmacokinetic (PK) Parameter: Tmax
2.080; 1.575; 2.070; 2.430
SECONDARY
Pharmacokinetic (PK) Parameter: t1/2
473.3; 426.4; 398.6; 526.8
SECONDARY
Pharmacokinetic (PK) Parameter: %AUCext
3.834; 2.120; 1.478; 4.005
SECONDARY
Pharmacokinetic (PK) Parameter: λz
0.001586; 0.001673; 0.001751; 0.001356
SECONDARY
Pharmacokinetic (PK) Parameter: CL
15.46; 14.98; 18.46; 17.20
SECONDARY
Pharmacokinetic (PK) Parameter: Vz
9848.9; 8880.3; 10532.2; 12805.5

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-P59 in Healthy Subjects.

Eligibility Criteria

Inclusion Criteria

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 19 to 55 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 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 is able to understand and to comply with protocol requirements, instructions, and restrictions.
  • 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

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 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
  • Subject had a history of or concurrent use of medications including any prior therapy of following(s):
  • 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
  • Any vaccination within 4 weeks prior to the study drug 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
  • Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04525079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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