Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants

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)

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:

• Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
• Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
• Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CT-G11; Drug: CT-G20; Drug: CT-G11 Placebo; Drug: CT-G20 Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• body mass index (BMI) ≥18.0 and ≤30.0 kg/m2

Exclusion Criteria:

• Clinically significant allergic reactions
• Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
• Hepatic dysfunction upper limit of normal laboratory range
• Cardiac history or presence
• History or any concomitant active malignancy
• A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Inherited bleeding diathesis or coagulopathy with the risk of bleeding
• Hemoptysis, thrombotic or hemorrhagic event
• Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
• History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
• Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-G11; CT-G11 Experimental Drug	Drug: CT-G11; oral tablet of CT-G11 Experimental Drug
Experimental: CT-G20; CT-G20 Experimental Drug	Drug: CT-G20; oral tablet of CT-G20 Experimental Drug
Placebo Comparator: CT-G11 Placebo	Drug: CT-G11 Placebo; oral tablet of Placebo
Placebo Comparator: CT-G20 Placebo	Drug: CT-G20 Placebo; oral tablet of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse events including serious Adverse events (Part I, Part II)	46 days
Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)	Up to 48 hours after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety parameters as assessed by: QT interval of ECG	17 Days
Safety parameters as assessed by: QTcF of ECG	17 Days
Safety parameters as assessed by: blood pressure of Vital signs	17 Days
Safety parameters as assessed by: pulse rate of Vital signs	17 Days
Safety parameters as assessed by: body temperature of Vital signs	17 Days
Safety parameters as assessed by: hematology of Clinical laboratory tests	17 Days
Safety parameters as assessed by: clinical chemistry	17 Days
PK parameters as assessed by : Area under the concentration-time curve (AUC)	13 Days
PK parameters as assessed by : Maximum observed concentration (Cmax)	13 Days
PK parameters as assessed by : Time to Cmax (tmax)	13 Days
PK parameters as assessed by : Terminal half-life time (t1/2)	13 Days
PD parameters as assessed by : Left ventricular ejection fraction (LVEF)	17 Days

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Principal Investigator: In-Jin Jang, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): June 6, 2020
• Study Completion (Actual): June 6, 2020

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CT-G20 1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No