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

• Status: Completed
• Trial end date: 2020-06-06
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Celltrion

Criteria

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