A Study of HY209 in Healthy Male Volunteers for Sepsis
- Registration Number
- NCT04255979
- Lead Sponsor
- Shaperon
- Brief Summary
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
HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 HY209 Single dose of HY209 0.4 mg/kg or placebo. Cohort 6 HY209 Single dose of HY209 3.2 mg/kg or placebo. Cohort 4 HY209 Single dose of HY209 0.8 mg/kg or placebo. Cohort 5 HY209 Single dose of HY209 1.6 mg/kg or placebo. Cohort 1 HY209 Single dose of HY209 0.1 mg/kg or placebo. Cohort 2 HY209 Single dose of HY209 0.2 mg/kg or placebo.
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) Up to Day 6 Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax) of HY209 Up to Day 2 Maximum concentration of HY209 in plasma
Time of maximum concentration (Tmax) of HY209 Up to Day 2 Time of maximum concentration of HY209 in plasma
Terminal halif-life (t1/2) of HY209 Up to Day 2 Terminal half-life of HY209 in plasma
Ratio of area under curve infinity (AUCinf) of HY209 Up to Day 2 Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity
Ratio of area under curve last (AUClast) of HY209 Up to Day 2 Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of