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A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)

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Trial Profile

A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jun 2020

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At a glance

  • Drugs CT G11 (Primary) ; CT G20 (Primary)
  • Indications Cardiovascular disorders; Hypertrophic cardiomyopathy
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Celltrion

    • Most Recent Events

    • 07 Jun 2020 Status changed from recruiting to completed.
    • 11 Mar 2020 Trial focus, number of participants, outcome measures has been amended.
    • 11 Mar 2020 Planned number of patients changed from 48 to 72.

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