Status:
COMPLETED
Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
A randomized, placebo-controlled, dose-escalation, crossover study.
Detailed 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 administr...
Eligibility Criteria
Inclusion
- Key
- Subject who signed voluntarily the written agreement after understanding the purpose, contents, the properties and expected adverse effects of investigational product
- Subject who is considered to be appropriate for the study according to the judgment of investigator based on physical examination, clinical laboratory test, electrocardiogram, vital sign and questionnaire
- Key
Exclusion
- Subject with clinically meaningful and relevant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system and mental system
- Subject with sensitive reaction in HDAC inhibitor or another drug
- Subject who participated in another clinical trial or bioequivalent study with past 6 weeks
- Subject who is not considered to be appropriate for the study according to the judgment of investigator
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05345912
Start Date
December 16 2019
End Date
May 19 2021
Last Update
April 26 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080