Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
NCT ID: NCT03918967
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2019-04-08
2020-06-06
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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CT-G11
CT-G11 Experimental Drug
CT-G11
oral tablet of CT-G11 Experimental Drug
CT-G20
CT-G20 Experimental Drug
CT-G20
oral tablet of CT-G20 Experimental Drug
CT-G11 Placebo
CT-G11 Placebo
oral tablet of Placebo
CT-G20 Placebo
CT-G20 Placebo
oral tablet of Placebo
Interventions
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CT-G11
oral tablet of CT-G11 Experimental Drug
CT-G20
oral tablet of CT-G20 Experimental Drug
CT-G11 Placebo
oral tablet of Placebo
CT-G20 Placebo
oral tablet of Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
55 Years
MALE
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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In-Jin Jang
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CT-G20 1.1
Identifier Type: -
Identifier Source: org_study_id
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