A clinical study to evaluate the safety and tolerability of ES16001 after oral administration in healthy subjects

• Register: KCT
• Last refreshed on: 22 April 2021
• Main ID: KCT0006066
• Date of registration: 2021-04-07
• Prospective Registration: No
• Primary sponsor: Seoul National University Bundang Hospital
• Public title: A clinical study to evaluate the safety and tolerability of ES16001 after oral administration in healthy subjects
• Scientific title: Dosage-randomized, double-blind, placebo-controlled, clinical trial to assess safety and tolerability after single or multiple oral administration of "ES16001" in healthy volunteers
• Date of first enrolment: 2019-11-18
• Target sample size: 48
• Recruitment status: Completed
• URL: https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=19071
• Study type: Interventional Study
• Study design: Primary Purpose : Treatment, Intervention Model : Factorial, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
• Phase: Phase1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Byungwook Kim
• Affiliation: Seoul National University Hospital

• Name: Jae-Yong Chung
• Affiliation: Seoul National University Bundang Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy adults aged 20 or older and 45 or younger at the time of screening test
- A person who has no congenital or treatment-related chronic disease and has no pathological symptoms or findings as a result of an internal examination;
- A person who is deemed suitable for clinical trials as a result of laboratory and ECG tests such as serum tests, hematologic tests, hemochemical tests, and urinary tests during screening tests
2. A person who weighs more than 55 kg at the time of screening and weighs less than ±20% of the ideal body weight.
* Ideal body weight = (height (cm) - 100) × 0.9)
3. A person who agrees not to donate sperm during the clinical trial period and up to three months after the end of the trial.
4. Persons identified as non-pregnant
5. A person who, after receiving a detailed explanation of this clinical trial, voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion criteria: 1. A person with a medical history such as clinically significant and/or active cardiovascular, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, mental illness, or malignancy
2. Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs for clinical trials
3. A person with a history of hypersensitivity reaction to any medications or additives for clinical trials
4. A person who is deemed inappropriate for the clinical trial through a medical examination (disease intensity, physical examination, vital signs, ECG examination, laboratory examination, etc.) conducted during screening.
5. A person who shows the following laboratory test results
- Hemoglobin < 13.0 g/dL
- 1.5 times the UNL of blood AST or ALT
- Total bilirubin > 1.5 times the upper limit
- 1.5 times the upper limit of CPK in blood
- MDRD (Modification of Diet in Renal Disease) < 60 mL/min/1.73 m2
6. A person identified as a chronic hepatitis B and hepatitis C carrier
7. After a break of more than 5 minutes, systolic blood pressure > 150 mmHg or <100 mmHg, and/or diastolic blood pressure >100 mmHg or <60 mmHg.
8. 12-lead ECG indicates QTcB interval greater than 450ms
9. A person who has a history of drug abuse or who has tested positive for a drug that may be misused
10. Excessive caffeine and alcohol intake, smokers (caffeine: >5 cups/day, alcohol: >210 g/week, tobacco: >10 pcs/day)
11. A person who has received a clinical trial drug within 180 days prior to the administration of a clinical trial drug
12. A person who has taken medication that induces and inhibits metabolic enzymes such as barbital drug within 30 days prior to administration of a clinical trial drug
13. A person who has donated whole blood within 60 days prior to administration of a clinical trial drug, or a person who has donated blood within 30 days prior to administration of a clinical trial drug, or who has received blood transfusion within 30 days
14. A person who has consumed grapefruit-containing food (e.g. > 1L or more grapefruit-containing beverages) within 14 days prior to administration of the clinical trial drug
15. A person who has taken a specialized medicine, herbal medicine, general medicine, or vitamin pill within 14 days prior to administration of a clinical trial drug
16. A person who determines that the tester is unfit to participate in a clinical trial due to other reasons

Age minimum: 20(Year)
Age maximum: 45(Year)
Gender: Both

Health Condition(s) or Problem(s) studied

Certain infectious and parasitic diseases

Intervention(s)

Drug : Drug Name: ES16001
Target: Healthy Adult Volunteers
Step 1: 32 (8 per cohort)
Step 2: 16 (8 per cohort)
6 test subjects per cohort, 2 placebo subjects per cohort (total of 8)

Dosage and administration methods

Single dose group (Step1)
Cohort1: ES16001 240mg
Cohort2: ES16001 480mg
Cohort3: ES16001 960mg
Cohort4: ES16001 1,440mg

Multiple dose group (Step2)
Cohort5: ES16001 480 mg/day, administered for 5 days
Cohort6: ES16001 960 mg/day, administered for 5 days

Primary Outcome(s)

Adverse event

Secondary Outcome(s)

Laboratory test results

Vital sign

Source(s) of Monetary Support

Seoul National University Bundang Hospital

Ethics review

Status: Submitted approval
Approval date: 30/09/2019
Contact:

Seoul National University Bundang Hospital Institutional Review Board

[phone]

Results

• Date Completed: 26/05/2020