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

NCT05345912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-26

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

CG-745 IV Solution

CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion

DRUG

CG-750 125mg capsule

CG-750 capsule: Supplied as 125 mg/capsule Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3

OTHER

PO Placebo

PO Placebo: Supplied as placebo capsule (same appearance as in CG-750 Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3

OTHER

IV Placebo: 0.9 % normal saline

IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion

Sponsors & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • SeungHwan Lee, Ph.D · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-09-18
Completion
2021-05-19

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345912 on ClinicalTrials.gov