Study to Evaluate Pharmacokinetics, Safety, and Tolerability Ildong COL-144 Tablet in Korean Healthy Volunteers

A Randomized, Double Blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate Pharmacokinetics, Safety, and Tolerability With Oral Administration of Ildong COL-144 Tablet in Korean Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03937648

Enrollment

Registered

2019-05-06

Start date

2019-08-01

Completion date

2019-12-31

Last updated

2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

A Randomized, Double blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate Pharmacokinetics, Safety, and Tolerability with Oral Administration of Ildong COL-144 tablet in Korean Healthy Volunteers

Interventions

DRUGCOL-144 50mg

COL-144 50mg

DRUGCOL-144 100mg

COL-144 100mg

DRUGCOL-144 200mg

COL-144 200mg

DRUGCOL-144 400mg

COL-144 400mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. A healthy adult who is at least 19 years old and less than 50 years old at the time of the screening visit. 2. A person whose body mass index (BMI) is greater than 19 kg/m2 and less than 28 kg/m2 at the time of the screening visit. 3. A person who is medically confirmed to be clinically insignificant in terms of a physical or mental condition by an investigator through a physical examination during the screening period. 4. A person who has agreed to use a combination of effective contraceptive methods or medically appropriate contraceptive methods from the date of administration of the investigational product to the end of the clinical trial (date of test for final safety assessment). 5. A male or female who has agreed not to provide sperm or eggs. 6. A woman whose serum/urine human chorionic gonadotropin (hCG) test results were negative and who is not pregnant or breastfeeding. 7. A person who has voluntarily decided and provided written consent to participate in clinical trials and follow precautions for test subjects. 8. A person who can collect blood and urine during the clinical trial, including follow-up visits.

Exclusion criteria

1. A person with a history of gastrointestinal disorders (ex. Crohn's disease, ulcerative colitis, etc.) or surgery (except for simple appendectomy or herniotomy) that may affect the absorption of the investigational product. 2. In addition to

Design outcomes

Primary

Measure	Time frame
Cmax(maximum serum concentration)	0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours)
AUClast(rea under the curve from the time of dosing to the last measurable concentration)	0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours)
tmax(Time to reach maximum plasma concentration)	0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours)
CL/F(Clearance)	0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026