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A Study of HY209 in Healthy Male Volunteers for Sepsis

Primary Purpose

Sepsis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HY209

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Arm Description

Single dose of HY209 0.1 mg/kg or placebo.

Single dose of HY209 0.2 mg/kg or placebo.

Single dose of HY209 0.4 mg/kg or placebo.

Single dose of HY209 0.8 mg/kg or placebo.

Single dose of HY209 1.6 mg/kg or placebo.

Single dose of HY209 3.2 mg/kg or placebo.

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events (TEAEs)

Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment

Secondary Outcome Measures

Maximum concentration (Cmax) of HY209

Maximum concentration of HY209 in plasma

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

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

Time of maximum concentration (Tmax) of HY209

Time of maximum concentration of HY209 in plasma

Terminal halif-life (t1/2) of HY209

Terminal half-life of HY209 in plasma

Full Information

NCT ID

NCT04255979

First Posted

February 3, 2020

Last Updated

November 27, 2020

Sponsor

Shaperon

1. Study Identification

Unique Protocol Identification Number

NCT04255979

Brief Title

A Study of HY209 in Healthy Male Volunteers for Sepsis

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

December 5, 2019 (Actual)

Primary Completion Date

June 12, 2020 (Actual)

Study Completion Date

June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shaperon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, placebo-controlled single dosing, dose escalation

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Single dose of HY209 0.1 mg/kg or placebo.

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Single dose of HY209 0.2 mg/kg or placebo.

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Single dose of HY209 0.4 mg/kg or placebo.

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Single dose of HY209 0.8 mg/kg or placebo.

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

Single dose of HY209 1.6 mg/kg or placebo.

Arm Title

Cohort 6

Arm Type

Experimental

Arm Description

Single dose of HY209 3.2 mg/kg or placebo.

Intervention Type

Drug

Intervention Name(s)

HY209

Other Intervention Name(s)

HY209-IV

Intervention Description

6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events (TEAEs)

Description

Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment

Time Frame

Up to Day 6

Secondary Outcome Measure Information:

Title

Maximum concentration (Cmax) of HY209

Description

Maximum concentration of HY209 in plasma

Time Frame

Up to Day 2

Title

Ratio of area under curve infinity (AUCinf) of HY209

Description

Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity

Time Frame

Up to Day 2

Title

Ratio of area under curve last (AUClast) of HY209

Description

Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration

Time Frame

Up to Day 2

Title

Time of maximum concentration (Tmax) of HY209

Description

Time of maximum concentration of HY209 in plasma

Time Frame

Up to Day 2

Title

Terminal halif-life (t1/2) of HY209

Description

Terminal half-life of HY209 in plasma

Time Frame

Up to Day 2

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-jin Jang

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

State/Province

Jongno-gu

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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A Study of HY209 in Healthy Male Volunteers for Sepsis

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