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

Shaperon1 site in 1 country40 target enrollmentDecember 5, 2019

ConditionsSepsis

InterventionsHY209

DrugsHY209

Overview

Phase: Phase 1
Intervention: HY209
Conditions: Sepsis
Sponsor: Shaperon
Enrollment: 40
Locations: 1
Primary Endpoint: Incidence of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 5, 2019

End Date

June 12, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Shaperon

Responsible Party

Sponsor

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