A Study of HY209 in Healthy Male Volunteers for Sepsis

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255979
• Other study ID #: HY209-IV
• Status: Completed
• Phase: Phase 1
• Start date: December 5, 2019
• Est. completion date: June 12, 2020

Study information

• Verified date: November 2020
• Source: Shaperon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Shaperon

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum concentration (Cmax) of HY209	Maximum concentration of HY209 in plasma	Up to Day 2
Secondary	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
Secondary	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
Secondary	Time of maximum concentration (Tmax) of HY209	Time of maximum concentration of HY209 in plasma	Up to Day 2
Secondary	Terminal halif-life (t1/2) of HY209	Terminal half-life of HY209 in plasma	Up to Day 2