drugset / Trial / NCT03918967

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

NCT03918967 ↗

Phase 1 Completed 72 enrolled Celltrion
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2019-04-08
Primary completion
2020-06-06
Completion
2020-06-06

Drugs

EvaluationDrugModalityDoseRoute
Subject CT-G11 Unknown — Oral
Subject CT-G20 Unknown — Oral

Indications

No indication recorded.