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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CT-G20 Placebo; Drug: CT-G11 Placebo; Drug: CT-G11; Drug: CT-G20

• Registration Number: NCT03918967
• Lead Sponsor: Celltrion

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-08
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Status Verified: 2020-06
• Primary Completion: 2020-06-06
• Study Completion: 2020-06-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CT-G20 Placebo	CT-G20 Placebo	-
CT-G11 Placebo	CT-G11 Placebo	-
CT-G11	CT-G11	CT-G11 Experimental Drug
CT-G20	CT-G20	CT-G20 Experimental Drug

Primary Outcome Measures

Name	Time	Method
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
Incidence of Adverse events including serious Adverse events (Part I, Part II)	46 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of