A Study of HY209 in Healthy Male Volunteers for Sepsis

Study Overview
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Brief Summary
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A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers

Detailed Description
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HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).

Official Title
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A Randomized, Double-blind, Placebo-controlled Single Dosing, Dose Escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of HY209 After Intravenous Administration in Healthy Male Volunteers

Conditions
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Sepsis

Intervention / Treatment
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* Drug: HY209


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged from 19 to 45 at screening test BMI 18 kg/m2   27 kg/m2 at screening test Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion Exclusion Criteria: Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.) Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit [Systolic blood pressure (SBP): < 90 mmHg or > 150 mmHg, Diastolic blood pressure (DBP): < 50 mmHg or > 90 mmHg] Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week Caffeine overdose, alcohol overdose or oversmoker Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial Other investigator judged to be unsuitable as clinical subject

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled single dosing, dose escalation
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single dose of HY209 0.1 mg/kg or placebo. | Drug: HY209<br>* 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.<br>* Other names: HY209-IV;|
| Experimental: Cohort 2<br>Single dose of HY209 0.2 mg/kg or placebo. | Drug: HY209<br>* 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.<br>* Other names: HY209-IV;|
| Experimental: Cohort 3<br>Single dose of HY209 0.4 mg/kg or placebo. | Drug: HY209<br>* 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.<br>* Other names: HY209-IV;|
| Experimental: Cohort 4<br>Single dose of HY209 0.8 mg/kg or placebo. | Drug: HY209<br>* 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.<br>* Other names: HY209-IV;|
| Experimental: Cohort 5<br>Single dose of HY209 1.6 mg/kg or placebo. | Drug: HY209<br>* 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.<br>* Other names: HY209-IV;|
| Experimental: Cohort 6<br>Single dose of HY209 3.2 mg/kg or placebo. | Drug: HY209<br>* 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.<br>* Other names: HY209-IV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events (TEAEs) | Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment | Up to Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) of HY209 | Maximum concentration of HY209 in plasma | Up to Day 2 | 
| Ratio of area under curve infinity (AUCinf) of HY209 | Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity | Up to Day 2 | 
| Ratio of area under curve last (AUClast) of HY209 | Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration | Up to Day 2 | 
| Time of maximum concentration (Tmax) of HY209 | Time of maximum concentration of HY209 in plasma | Up to Day 2 | 
| Terminal halif-life (t1/2) of HY209 | Terminal half-life of HY209 in plasma | Up to Day 2 |