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

NCT03918967 | Completed Phase 1

• 1 other identifier: CT-G20 1.1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Study Arms (4)

CT-G11

EXPERIMENTAL

CT-G11 Experimental Drug

Drug: CT-G11

CT-G20

EXPERIMENTAL

CT-G20 Experimental Drug

Drug: CT-G20

CT-G11 Placebo

PLACEBO COMPARATOR

Drug: CT-G11 Placebo

CT-G20 Placebo

PLACEBO COMPARATOR

Drug: CT-G20 Placebo

Interventions

CT-G11 DRUG

oral tablet of CT-G11 Experimental Drug

CT-G11

CT-G20 DRUG

oral tablet of CT-G20 Experimental Drug

CT-G20

CT-G11 Placebo DRUG

oral tablet of Placebo

CT-G11 Placebo

CT-G20 Placebo DRUG

oral tablet of Placebo

CT-G20 Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• In-Jin Jang

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 18, 2019
• Study Start: April 8, 2019
• Primary Completion: June 6, 2020
• Study Completion: June 6, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

KR (1)