A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

NCT05188378
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Phase
Phase 1
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Recruitment status
Unknown
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Participants
300
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Lead sponsor
Celltrion
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Start date
2021-12-22
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Number of sites
1
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Summary
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
clinicaltrials.gov
Short title
A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
clinicaltrials.gov
Official title
A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-01-31
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First posted
2022-01-12
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Registry last updated
2022-01-12
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Primary completion date
2022-10-01
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Start date
2021-12-22
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Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
0
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Randomisation ratio
1:1
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Celltrion
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05188378
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ClinicalTrials.gov ID
NCT05188378
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Other
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Primary objective

    Timeframe: up to Day 43

    To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)

  2. Primary objective

    Timeframe: up to Day 43

    To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)

  3. Primary objective

    Timeframe: up to Day 43

    To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
19 Years
Maximum age
55 Years
Healthy volunteers
Yes

  • Healthy subjects
  • Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth

  • A medical history and/or condition that is considered significant
  • Clinically significant allergic reactions, hypersensitivity
  • History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
  • Active or latent Tuberculosis
  • History of malignancy
  • Previous exposure to tocilizumab or any drug that targets IL-6
Sources for eligibility
clinicaltrials.gov

  • Seoul National University HospitalSeoul, South KoreaRecruiting
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)