Overview

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:
Participant gender:
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
Details
Lead Sponsor:
Celltrion