A Study of HY209 in Healthy Male Volunteers for Sepsis

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

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

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: HY209

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shaperon
• Investigators: Principal Investigator: In-Jin Jang, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: HY209-IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No