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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CT-G20 Placebo; Drug: CT-G11; Drug: CT-G11 Placebo; Drug: CT-G20

Study type: Interventional

Funder types: Industry

Identifiers

NCT03918967

CT-G20 1.1

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

CT-G11

Experimental group

Description:

CT-G11 Experimental Drug

Treatment:

Drug: CT-G11

CT-G20

Experimental group

Description:

CT-G20 Experimental Drug

Treatment:

Drug: CT-G20

CT-G11 Placebo

Placebo Comparator group

Treatment:

Drug: CT-G11 Placebo

CT-G20 Placebo

Placebo Comparator group

Treatment:

Drug: CT-G20 Placebo