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Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults

Healthy Clinical Trial

Official title:
A Randomized, Double Blind, Placebo-controlled, Dose-escalation, Crossover Study to Compare and Evaluate the Pharmacokinetics and Safety of 'CG-745 IV' Intravenous Formulation and 'CG-750' Capsule Formulation in Healthy Male Adults

Clinical Trial Summary

A randomized, placebo-controlled, dose-escalation, crossover study.

Clinical Trial Description

Total of 24 health volunteers will be randomized to receive either of Cohort 1,2 or 3. (8 subjects each) [Cohort 1] Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated CG-750 capsule or placebo with 150 mL of water. [Cohort 2] The recommended dose of capsule in cohort 2 will be determined based on the bioavailabilty and safety data of cohort 1. Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 capsules or placebo with 150 mL of water. After 2-week rest period, subject will take the high fat diet and then be administrated the determined dose of CG-750 or placebo with 150 mL of water. [Cohort 3] The recommended dose of capsule in cohort 3 will be determined based on the bioavailabilty of cohort 1 and 2. Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 or placebo with 150 mL of water. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05345912
Study type Interventional
Source CrystalGenomics, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 16, 2019
Completion date May 19, 2021
View Details
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