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Studies

Interventional Recruiting Phase 1

NCT05617183 on ClinicalTrials.gov

Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

Official title: A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

  • Sponsor: Celltrion (South Korea)
  • Enrollment: 268 (Estimated)
  • Study start: 2022-11-15 (Actual)
  • Primary completion: 2023-04-01 (Estimated)
  • Study completion: 2023-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

Conditions

  • Healthy Subjects

Intervention / Treatment

  • Biological: CT-P47

Primary Outcome Measures

  • PK similarity demonstration by AUC (Day 43)
    Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P47 SC administration via AI versus PFS in healthy subjects up to Day 43. The similarity of PK between CT-P47 AI vs CT-P47 PFS will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for AUC0-inf.
  • PK similarity demonstration by Cmax (Day 43)
    Demonstrate PK similarity in terms of maximum serum concentration (Cmax) of CT-P47 SC administration via AI versus PFS in healthy subjects up to Day 43. The similarity of PK between CT-P47 AI vs CT-P47 PFS will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for Cmax.

Countries

Korea, Republic of

Locations and Investigators

  • Seoul National University Hospital, Seoul, Korea, Republic of (Recruiting)
    • KyungSang Yu

Study Officials

  • KyungSang Yu (Principal Investigator) — Seoul National University College of Medicine and Hospital